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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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)
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Krakow, Poland
inhibition of platelet aggregation
inhibition of platelet aggregation at the 30-day follow-up visit.
Time frame: at 30 days follow-up
inhibition of platelet aggregation
inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
Time frame: at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
Time frame: at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
Time frame: at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Time frame: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Secondary outcome
frequency of bleeding complications within 30 days
Time frame: 30 days
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