Antithrombotic triple therapy and coagulation activation at the site of thrombus formation: a randomized trial in healthy subjects
Summary Background Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in a...
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| Published in | Journal of thrombosis and haemostasis Vol. 12; no. 11; pp. 1850 - 1860 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Limited
01.11.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1538-7933 1538-7836 1538-7836 |
| DOI | 10.1111/jth.12726 |
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| Abstract | Summary
Background
Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature.
Methods and Results
Platelet activation (β‐thromboglobulin [β‐TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2], thrombin‐antithrombin complex [TAT]) were studied in an open‐label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0–3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood β‐TG and were more pronounced than phenprocoumon at an INR of 2.0–3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of β‐TG, F1+2 and TAT at 3 h post‐dosing was noted, which remained below pre‐dose levels at trough steady state.
Conclusion
A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo. |
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| AbstractList | Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature.BACKGROUNDPatients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature.Platelet activation (β-thromboglobulin [β-TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2 ], thrombin-antithrombin complex [TAT]) were studied in an open-label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0-3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood β-TG and were more pronounced than phenprocoumon at an INR of 2.0-3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of β-TG, F1+2 and TAT at 3 h post-dosing was noted, which remained below pre-dose levels at trough steady state.METHODS AND RESULTSPlatelet activation (β-thromboglobulin [β-TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2 ], thrombin-antithrombin complex [TAT]) were studied in an open-label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0-3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood β-TG and were more pronounced than phenprocoumon at an INR of 2.0-3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of β-TG, F1+2 and TAT at 3 h post-dosing was noted, which remained below pre-dose levels at trough steady state.A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo.CONCLUSIONA triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo. Summary Background Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature. Methods and Results Platelet activation (β‐thromboglobulin [β‐TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2], thrombin‐antithrombin complex [TAT]) were studied in an open‐label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0–3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood β‐TG and were more pronounced than phenprocoumon at an INR of 2.0–3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of β‐TG, F1+2 and TAT at 3 h post‐dosing was noted, which remained below pre‐dose levels at trough steady state. Conclusion A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo. Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature. Platelet activation (β-thromboglobulin [β-TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2 ], thrombin-antithrombin complex [TAT]) were studied in an open-label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0-3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood β-TG and were more pronounced than phenprocoumon at an INR of 2.0-3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of β-TG, F1+2 and TAT at 3 h post-dosing was noted, which remained below pre-dose levels at trough steady state. A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo. Summary Background Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor. We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature. Methods and Results Platelet activation ([beta]-thromboglobulin [[beta]-TG]) and thrombin generation (prothrombin fragment 1 + 2 [F1+2], thrombin-antithrombin complex [TAT]) were studied in an open-label, randomized, parallel group trial in 60 healthy male subjects (n = 20 per group) who received ticagrelor and acetylsalicylic acid (ASA) in combination with dabigatran (150 mg bid), rivaroxaban (20 mg od) or phenprocoumon (INR 2.0-3.0). Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions. Single doses of ticagrelor, dabigatran or rivaroxaban caused comparable decreases in shed blood [beta]-TG and were more pronounced than phenprocoumon at an INR of 2.0-3.0. In contrast, thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran. During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of [beta]-TG,F1+2 and TAT at 3 h post-dosing was noted, which remained below pre-dose levels at trough steady state. Conclusion A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo. |
| Author | Litschauer, B. Eichinger, S. Wolzt, M. Mayer, P. Kyrle, P. A. Weisshaar, S. Smerda, L. Gouya, G. Kapiotis, S. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25211369$$D View this record in MEDLINE/PubMed |
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Background
Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of... Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and... Summary Background Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of... |
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| SubjectTerms | Adenosine - administration & dosage Adenosine - adverse effects Adenosine - analogs & derivatives Adenosine - pharmacokinetics Administration, Oral Adult Anticoagulants - administration & dosage Anticoagulants - adverse effects Antithrombin III aspirin Aspirin - administration & dosage Aspirin - adverse effects Austria Benzimidazoles - administration & dosage Benzimidazoles - adverse effects Benzimidazoles - pharmacokinetics beta-Alanine - administration & dosage beta-Alanine - adverse effects beta-Alanine - analogs & derivatives beta-Alanine - pharmacokinetics beta-Thromboglobulin - metabolism Biomarkers - blood Blood Coagulation - drug effects Blood Platelets - drug effects Blood Platelets - metabolism Dabigatran Drug Therapy, Combination Fibrinolytic Agents - administration & dosage Fibrinolytic Agents - adverse effects Healthy Volunteers Humans International Normalized Ratio Male Morpholines - administration & dosage Morpholines - adverse effects Morpholines - pharmacokinetics Peptide Fragments - blood Peptide Hydrolases - blood phenprocoumon Phenprocoumon - administration & dosage Phenprocoumon - adverse effects Platelet Activation - drug effects Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Prospective Studies Prothrombin Rivaroxaban Thiophenes - administration & dosage Thiophenes - adverse effects Thiophenes - pharmacokinetics Thrombin - metabolism Thrombosis - blood Thrombosis - diagnosis Thrombosis - drug therapy ticagrelor Young Adult |
| Title | Antithrombotic triple therapy and coagulation activation at the site of thrombus formation: a randomized trial in healthy subjects |
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