DRUG
Bivalirudin
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
Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI
Status
Completed
Phase
Phase 4
Enrollment
2,989
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Full detailed description
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.
Interventions
Treatment arms and agents.
DRUG
Enoxaparin
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
DRUG
Unfractionated heparin
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
DRUG
Bivalirudin placebo
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
DRUG
Enoxaparin placebo syringe
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.
DRUG
Unfractionated heparin placebo
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
Timeline
From registration to results.
First posted
Sep 10, 2018
Study start
Jan 11, 2019
Primary completion
Nov 23, 2022
Study completion
Nov 23, 2022
Results posted
Not reported
Registry updated
May 3, 2023
Outcomes
What the study measures.
Primary outcomes
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)
Time frame · 30 days
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
Primary safety endpoint - The number of event of major bleeding
Time frame · 30 days
The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
Secondary outcomes
Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time frame · 30 days
The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
Time frame · 30 days
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
Secondary ischemic endpoints - The number of cardiovascular death events
Time frame · 30 days
The number of cardiovascular death event within 30 days after randomization
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
Time frame · 30 days
The number of stent thrombosis (ARC definite) event within 30 days after randomization
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
Time frame · 30 days
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.
Secondary safety endpoints - The number of thrombocytopenia events
Time frame · 30 days
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years old * STEMI with PPCI of culprit lesion * Bivalirudin therapy during PPCI * Signed informed consent form Exclusion Criteria: * Patients with a formal indication for anticoagulation after PPCI (e.g. atrial fibrillation, left-ventricular thrombus, intra-aortic balloon pump, pulmonary embolism, mechanical heart valve) * Patients with any indication for chronic anticoagulation * Patient with previous lytic treatment * Patient with previous coronary artery bypass graft surgery * Cardiogenic shock, malignant ventricular arrhythmia, or mechanical complications * Any anticoagulation other than bivalirudin started after the procedure before randomization * Estimated body weight of \>120 kg or \<45kg * BP ≥180/110mmHg at randomization * Any bleeding diathesis or severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (\<6months) ischemic stroke or TIA, recent (\<6months) intracranial hemorrhage or, gastrointestinal or genitourinary bleeding within the past 2 weeks * History of heparin-induced thrombocytopenia * Suspected acute aortic dissection (AAD) * Major surgery within 1 month * A planned elective surgical procedure that would necessitate an interruption in treatment with P2Y12 inhibitors in the next 6 months after enrollment * Known PLT≤100×109 or HGB≤10g/L * Known transaminase \>3-fold ULN, or CCr\<30ml/min * Known allergy to any study drug * Pregnancy or lactation * Noncardiac coexisting conditions that could limit life expectancy to less than 1 year * Current participation in an investigational drug or device trial
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Publications
Results and literature.
PMID 32663660 ↗Yan Y, Wang X, Guo J, Li Y, Ai H, Gong W, Que B, Zhen L, Lu J, Ma C, Montalescot G, Nie S. Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Am Heart J. 2020 Sep;227:19-30. doi: 10.1016/j.ahj.2020.06.005. Epub 2020 Jun 20.PMID 42171583 ↗Yan Y, Wang X, Fan Z, Guo J, Wang G, Yin D, Wang Z, Zhang F, Tian C, Gong W, Liu J, Lu J, Ma C, Vicaut E, Montalescot G, Nie S; RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention: 1-Year Results From the RIGHT Trial and Meta-analyses. JACC Asia. 2026 Jul;6(7):1095-1105. doi: 10.1016/j.jacasi.2026.04.003. Epub 2026 May 22.PMID 38406848 ↗Yan Y, Guo J, Wang X, Wang G, Fan Z, Yin D, Wang Z, Zhang F, Tian C, Gong W, Liu J, Lu J, Li Y, Ma C, Vicaut E, Montalescot G, Nie S; RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial. Circulation. 2024 Apr 16;149(16):1258-1267. doi: 10.1161/CIRCULATIONAHA.123.067079. Epub 2024 Feb 26.
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