Official Title
Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
Phase
Phase 4Lead Sponsor
Fundacja Ośrodek Badań MedycznychStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Acute Myocardial InfarctionIntervention/Treatment
clopidogrel ...Study Participants
0REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.
The objectives of the study is:
to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment
to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
Inclusion Criteria: •≥18 years of age, Myocardial Infarction with or without ST segment elevation, clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day), signed written informed consent. Exclusion Criteria: prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days, prior administration of prasugrel within the last 14 days, subject with known hypersensitivity to the active ingredient or other components of the product increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count < 100 000/mm3), oral anticoagulant therapy (INR >1.6), uncontrolled hypertension (systolic blood pressure >200 mmHg), major bleeding, trauma or surgery within the last 30 days, acute renal failure, acute liver failure, pregnancy.
