Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2989 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2022-11-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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STEMI - ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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anticoagulation

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

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

Enoxaparin

Intervention Type DRUG

40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later

Unfractionated heparin

Intervention Type DRUG

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

No anticoagulation

Group Type PLACEBO_COMPARATOR

Bivalirudin placebo

Intervention Type DRUG

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later

Enoxaparin placebo syringe

Intervention Type DRUG

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.

Unfractionated heparin placebo

Intervention Type DRUG

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.

Interventions

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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

Intervention Type DRUG

Enoxaparin

40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later

Intervention Type 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

Intervention Type DRUG

Bivalirudin placebo

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later

Intervention Type 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.

Intervention Type DRUG

Unfractionated heparin placebo

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No