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Sponsored by: |
Uppsala University |
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Information provided by: | Uppsala University |
ClinicalTrials.gov Identifier: | NCT00914368 |
The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.
Condition | Intervention | Phase |
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Coronary Artery Disease Myocardial Infarction Stent Thrombosis Heart Diseases Acute Coronary Syndrome |
Drug: Clopidogrel |
Phase II |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition |
Estimated Enrollment: | 450 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease
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Drug: Clopidogrel
Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.
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2: Active Comparator
Patients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease
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Drug: Clopidogrel
Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.
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3: Active Comparator
Patients without previously experienced myocardial infarction or stent thrombosis 6 within months after coronary stenting for coronary artery disease(matched controls for group 1 and 2)
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Drug: Clopidogrel
Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.
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To establish cut off levels of platelet inhibition using ADP-induced P2Y12-receptor mediated platelet aggregation using Accumetrics VerifyNow P2Y12 assay (PRU) and Vasodilator-stimulated phosphoprotein (VASP, PRI %)for patients with experienced stent occlusion with acute clinical onset and/or myocardial infarction within 6 months after coronary stenting for coronary artery disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Experienced one of the following alternatives:
Exclusion Criteria:
General exclusion criteria:
Cardiovascular Exclusion Criteria:
Bleeding Risk Exclusion Criteria:
Contact: Susanne Heller, PhD | +46 18 611 95 51 | susanne.heller@ucr.uu.se |
Contact: Christoph Varenhorst, MD | +46 73 201 67 67 | christoph.varenhorst@ucr.uu.se |
Sweden | |
Uppsala Clinical Research Center | Recruiting |
Uppsala, Sweden, 75185 |
Principal Investigator: | Lars Wallentin, MD, PhD | Uppsala University, Uppsala Clinical Research Center |
Responsible Party: | UCR, Uppsala University ( Lars Wallentin, MD, PhD. Professor Cardiology ) |
Study ID Numbers: | U-08-002 |
Study First Received: | May 29, 2009 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00914368 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
Platelet Aggregation Inhibitors Aspirin Clopidogrel Pathologic Processes Disease |
Therapeutic Uses Syndrome Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Thrombosis Coronary Disease Embolism and Thrombosis |
Necrosis Aspirin Embolism Clopidogrel Acute Coronary Syndrome Platelet Aggregation Inhibitors Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Disease Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases Ischemia Arteriosclerosis Pharmacologic Actions Thrombosis Coronary Disease Embolism and Thrombosis |
Necrosis Pathologic Processes Therapeutic Uses Clopidogrel Syndrome Acute Coronary Syndrome Platelet Aggregation Inhibitors Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |