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

Capital Medical University

Status and phase

Completed

Phase 4

Conditions

STEMI - ST Elevation Myocardial Infarction

Treatments

Drug: Bivalirudin placebo

Drug: Enoxaparin

Drug: Unfractionated heparin placebo

Drug: Unfractionated heparin

Drug: Bivalirudin

Drug: Enoxaparin placebo syringe

Study type

Interventional

Funder types

Other

Identifiers

NCT03664180

BJUHFRIGHT201802 (Other Identifier)

2018024X

Details and patient eligibility

About

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 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.

Enrollment

2,989 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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