Rationale and design of the Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51 (ATLAS-ACS 2 TIMI 51) trial: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome
Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a...
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| Published in | The American heart journal Vol. 161; no. 5; pp. 815 - 821.e6 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Mosby, Inc
01.05.2011
Mosby Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0002-8703 1097-6744 1097-6744 |
| DOI | 10.1016/j.ahj.2011.01.026 |
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| Abstract | Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96],
P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3.
The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery.
The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. |
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| AbstractList | Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96], P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3.BACKGROUNDAlthough therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96], P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3.The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery.DESIGNThe second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery.The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS.SUMMARYThe ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96], P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3. The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery. The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96], P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3. The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery. The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. Background Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96], P = .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3. Design The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery. Summary The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. Background Although therapy with aspirin or aspirin plus a thienopyridine reduces the incidence of long-term adverse cardiovascular events among patients with acute coronary syndrome (ACS), there remains a significant residual risk of cardiovascular death, recurrent myocardial infarction (MI), and stroke. In a phase 2 trial (ClinicalTrials.gov NCT00402597) in which the addition of the factor Xa inhibitor rivaroxaban was compared with placebo, among ACS patients receiving either aspirin alone or dual-antiplatelet therapy with aspirin and a thienopyridine, the end point of death, MI, or stroke compared with placebo was reduced (87/2331 [3.9%] vs 62/1160 [5.5%]; hazard ratio 0.69, [95% CI 0.50-0.96],P= .027). Two candidate doses of rivaroxaban were selected for further evaluation in a pivotal phase 3. Design The second ATLAS-ACS 2 TIMI 51 Trial is an international, randomized, double-blind, event-driven (n = 983) phase 3 trial involving more than 15,570 patients hospitalized with ACS (ClinicalTrials.gov NCT00809965). All patients are treated with a background of standard therapy including low-dose aspirin, and patients are stratified by the administration of a thienopyridine (clopidogrel or ticlopidine; stratum 2) or not (stratum 1). Within each stratum, patients are randomly assigned in a 1:1:1 ratio to receive rivaroxaban 2.5 mg twice daily, or rivaroxaban 5 mg twice daily, or placebo twice daily. The primary efficacy end point is the composite of cardiovascular death, MI, or stroke. The primary safety end point is thrombolysis in MI major bleeding not associated with coronary artery bypass graft surgery. The ATLAS-ACS 2 TIMI 51 is testing the hypothesis that anticoagulation with the oral factor Xa inhibitor rivaroxaban reduces cardiovascular death, MI, and stroke among patients with ACS treated with guideline-based therapies for ACS. |
| Author | Plotnikov, Alexei Gibson, C. Michael Goto, Shinya Cook-Bruns, Nancy Burton, Paul Bode, Christoph Mega, Jessica L. Sun, Xiang Verheugt, Freek Braunwald, Eugene |
| Author_xml | – sequence: 1 givenname: C. Michael surname: Gibson fullname: Gibson, C. Michael email: mgibson@perfuse.org organization: TIMI Study Group, Brigham and Women's Hospital, Boston, MA – sequence: 2 givenname: Jessica L. surname: Mega fullname: Mega, Jessica L. organization: TIMI Study Group, Brigham and Women's Hospital, Boston, MA – sequence: 3 givenname: Paul surname: Burton fullname: Burton, Paul organization: Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ – sequence: 4 givenname: Shinya surname: Goto fullname: Goto, Shinya organization: Tokai University School of Medicine Department of Medicine, Isehara, Kanagawa, Japan – sequence: 5 givenname: Freek surname: Verheugt fullname: Verheugt, Freek organization: Department of Cardiology OnzeLieveVrouweGasthuis (OLVG), Amsterdam, The Netherlands – sequence: 6 givenname: Christoph surname: Bode fullname: Bode, Christoph organization: University of Freiburg, Freiburg, Germany – sequence: 7 givenname: Alexei surname: Plotnikov fullname: Plotnikov, Alexei organization: Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ – sequence: 8 givenname: Xiang surname: Sun fullname: Sun, Xiang organization: Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ – sequence: 9 givenname: Nancy surname: Cook-Bruns fullname: Cook-Bruns, Nancy organization: Bayer-Schering Pharma, Berlin Germany – sequence: 10 givenname: Eugene surname: Braunwald fullname: Braunwald, Eugene organization: TIMI Study Group, Brigham and Women's Hospital, Boston, MA |
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| Copyright | 2011 Mosby, Inc. Mosby, Inc. 2015 INIST-CNRS Copyright © 2011 Mosby, Inc. All rights reserved. Copyright Elsevier Limited May 2011 |
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| Issue | 5 |
| Keywords | Human Myocardial infarction Atlas Addition Cardiovascular disease Standard Coronary heart disease Myocardial disease Fibrinolysis Standards Design Rivaroxaban Randomization Treatment Efficiency Placebo Double blind study Complication Clinical trial Circulatory system Safety Cardiology Acute coronary syndrome |
| Language | English |
| License | CC BY 4.0 Copyright © 2011 Mosby, Inc. All rights reserved. |
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| References | Hoshiba, Hatakeyama, Tanabe (bb0020) 2006; 4 Eriksson, Borris, Friedman (bb0040) 2008; 358 Lassen, Ageno, Borris (bb0045) 2008; 358 Rothberg, Celestin, Fiore (bb0030) 2005; 143 Chen, Jiang, Chen (bb0005) 2005; 366 Thygesen, Alpert, White (bb0075) 2007; 50 Kakkar, Brenner, Dahl (bb0050) 2008; 372 bb0085 Mega, Braunwald, Mohanavelu (bb0065) 2009; 374 Andreotti, Testa, Biondi-Zoccai (bb0025) 2006; 27 Kubitza (bb0060) 2008; 24 Antman, Cohen, Bernink (bb0070) 2000; 284 Sabatine, Cannon, Gibson (bb0010) 2005; 352 Turpie, Lassen, Davidson (bb0055) 2009; 373 Yusuf, Zhao, Mehta (bb0015) 2001; 345 Kubitza, Becka, Wensing (bb0035) 2005; 61 Hurst, Kind, Ruta (bb0080) 1997; 36 Kubitza (10.1016/j.ahj.2011.01.026_bb0035) 2005; 61 Yusuf (10.1016/j.ahj.2011.01.026_bb0015) 2001; 345 Andreotti (10.1016/j.ahj.2011.01.026_bb0025) 2006; 27 Chen (10.1016/j.ahj.2011.01.026_bb0005) 2005; 366 Eriksson (10.1016/j.ahj.2011.01.026_bb0040) 2008; 358 Kubitza (10.1016/j.ahj.2011.01.026_bb0060) 2008; 24 Thygesen (10.1016/j.ahj.2011.01.026_bb0075) 2007; 50 Sabatine (10.1016/j.ahj.2011.01.026_bb0010) 2005; 352 Kakkar (10.1016/j.ahj.2011.01.026_bb0050) 2008; 372 Antman (10.1016/j.ahj.2011.01.026_bb0070) 2000; 284 Rothberg (10.1016/j.ahj.2011.01.026_bb0030) 2005; 143 Mega (10.1016/j.ahj.2011.01.026_bb0065) 2009; 374 Hoshiba (10.1016/j.ahj.2011.01.026_bb0020) 2006; 4 Lassen (10.1016/j.ahj.2011.01.026_bb0045) 2008; 358 Turpie (10.1016/j.ahj.2011.01.026_bb0055) 2009; 373 Hurst (10.1016/j.ahj.2011.01.026_bb0080) 1997; 36 |
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| SubjectTerms | Acute Coronary Syndrome - diagnostic imaging Acute Coronary Syndrome - drug therapy Acute Coronary Syndrome - physiopathology Acute coronary syndromes Adolescent Adult Anticoagulants Anticoagulants - administration & dosage Aspirin Biological and medical sciences Biomarkers Bone surgery Cardiology. Vascular system Cardiovascular Coronary Angiography Coronary heart disease Double-Blind Method Drug dosages Electrocardiography Factor Xa Inhibitors Female Follow-Up Studies Heart Heart attacks Humans Ischemia Male Medical sciences Middle Aged Morpholines - administration & dosage Myocardial Infarction - diagnostic imaging Myocardial Infarction - drug therapy Myocardial Infarction - physiopathology Myocarditis. Cardiomyopathies Prospective Studies Rivaroxaban Stroke Thiophenes - administration & dosage Thrombolytic Therapy - methods Treatment Outcome Young Adult |
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| Title | Rationale and design of the Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51 (ATLAS-ACS 2 TIMI 51) trial: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome |
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