The RIGHT study is a large randomized study dedicated to post-PPCI anticoagulation in STEMI patients. The investigators propose to evaluate the clinical efficacy and safety of anticoagulation prolonged for at least 48 hours after the procedure vs. no prolongation of anticoagulation after procedure in patients with STEMI treated with bivalirudin during PPCI (primary hypothesis). When allocated to anticoagulation prolongation by randomization, the subject will be assigned to UFH, enoxaparin or bivalirudin (same regimen allocated by centre) for at least 48 hours after PPCI. The results from this study are expected to provide guidance on the risk/benefit of post-procedural anticoagulation in patients with STEMI.
A minor change of time of randomization after prolongation of bivalirudin infusion at PCI dose up to 4 hours on protocol at September 19,2018. Reasons: a minor change concerning the timing of randomization considering the current local practice in some centers that use the 4 hour infusion of bivalirudin just after PCI. It remains in agreement with the current international guidelines and with the drug label in China. There is no change in drugs used and doses of these drugs once the randomization occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,989
IV infusion of 0.2 mg/kg/h (low-rate infusion) for at least 48h after the procedure or until discharge from CCU if it occurs later
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
IV infusion of 10 U/kg/h (maximum 1000 U) initially, adjusted to maintain ACT between 150 and 220 seconds for at least 48h after the procedure or until discharge from CCU if it occurs later
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
Placebo syringe will be only prepared by a designated unblended medical professional on site. Placebo syringe will be presented in identical containers as a clear, colorless, sterile liquid of saline.Subcutaneous injection once a day for at least 48 hours after the procedure or until discharge from CCU if it occurs later.
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Primary efficacy endpoint - number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel)
The number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) within 30 days after randomization
Time frame: 30 days
Primary safety endpoint - The number of event of major bleeding
The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
Time frame: 30 days
Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization
Time frame: 30 days
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
Time frame: 30 days
Secondary ischemic endpoints - The number of cardiovascular death events
The number of cardiovascular death event within 30 days after randomization
Time frame: 30 days
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
The number of stent thrombosis (ARC definite) event within 30 days after randomization
Time frame: 30 days
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
The number of bleeding events (TIMI, STEEPLE and GUSTO definition) within 30 days after randomization To demonstrate that post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo is associated to lower rate of the composite endpoint of major bleeding according to TIMI, STEEPLE and GUSTO definitions within the first 30 days after randomization.
Time frame: 30 days
Secondary safety endpoints - The number of thrombocytopenia events
The number of thrombocytopenia events within 30 days after randomization To demonstrate superiority of a strategy of post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo by the time from randomization to the first occurrence of any event of the Thrombocytopenia endpoint over 30 days of follow-up.
Time frame: 30 days
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