Coronary Artery Disease Clinical Trial
Official title:
Dual Antiplatelet Therapy in Patients With Aspirin Resistance Following Coronary Artery Bypass Grafting
Reactive platelet hyperactivity following coronary artery bypass grafting (CABG) might lead
to thrombotic complications and major ischemic cardiac events. The aim of this study is to
evaluate the changes in platelet reactivity following CABG and to clarify a potentially
beneficial effect of dual antiplatelet therapy in the group of patients with documented
aspirin resistance following CABG. Platelet function will be assessed by multiple electrode
aggregometry. Aortocoronary vein graft disease is comprised of three distinct but
interrelated pathological processes: thrombosis, intimal hyperplasia and atherosclerosis.
Early vein thrombosis is a major cause of vein graft attrition during the first month after
CABG.
Bypass patency can be improved with antiplatelet therapy which is the mainstay of treatment
for patients after CABG. A beneficial effect of acetylsalicylic acid (ASA) on vein graft
patency has been previously shown. Some patients experience thrombotic events despite
continuous aspirin administration after CABG. The investigators hypothesized that low
responsiveness to aspirin might be a precipitating factor for adverse thrombotic events
following CABG.
Low responsiveness to ASA, as assessed by platelet function tests, varies widely among
patients. The etiology of postoperative platelet hyperactivity remains to be elucidated.
In this study a new point-of-care assay named multiple electrode aggregometry (MEA) using a
device called Multiplate analyzer (Dynabyte, Munich, Germany) has been utilized. It allows
for rapid and standardized assessment of platelet function parameters.
This is a prospective randomized trial. The aim of the study is to document whether
introduction of dual antiplatelet therapy in patients with ASA resistance will lead to a
lower incidence of major adverse cardiac events (MACE) at a six month follow up. The
composite endpoint will include death, non-fatal myocardial infarction, stroke and cardiac
rehospitalization. All patients will receive 300 mg of ASA starting 6 hours after surgery,
provided that the chest tube output is minimal. On postoperative day 4 their platelet
function will be assessed using the above mentioned MEA. The patients found to be aspirin
resistant will then undergo the process of randomization. The first arm will include
patients with ASA resistance in whom no additional antiaggregation will be administered. In
the second arm the investigators will include patients who were randomized to receive 75 mg
of clopidogrel in addition to the standard antiplatelet regimen of 300 mg of ASA.
Platelet function monitoring allows for individual tailoring of the antiplatelet therapy.
The goal of this study is to define whether this strategy will lead to improved patient
outcomes. Both major and minor bleeding complications will be strictly monitored and
reported.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Isolated coronary artery bypass grafting - Patients older than 18 years - Written informed consent - Accurate antiplatelet therapy administration documentation Exclusion Criteria: - Missing consent - Patients with cardiac surgical procedures other than isolated CABG - Antiplatelet therapy other than aspirin 300 mg after CABG - Previous PCI requiring clopidogrel therapy after CABG - Patients with unknown preoperative anti-platelet status - Urgent or emergent surgery - Off-pump CABG - Re-Do CABG - Patients younger than 18 years |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Croatia | Medical school Zagreb, University hospital center Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACE events | MACE: death; non-fatal myocardial infarction; stroke; cardiac rehospitalization | 6 months | Yes |
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