Acute Myocardial Infarction
Conditions
Keywords
STEMI, NSTEMI, clopidogrel, Areplex, REL-0609
Brief summary
REL-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.
Detailed description
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
Interventions
DRUGClopidogrel
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
Sponsors
KCRI
Fundacja Ośrodek Badań Medycznych
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inhibition of platelet aggregation | at 30 days follow-up | inhibition of platelet aggregation at the 30-day follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | 30 days | frequency of bleeding complications within 30 days |
Countries
Poland
Outcome results
None listed