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

Summary

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.

Conditions

• STEMI - ST Elevation Myocardial Infarction

Interventions

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

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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France

  collaborator UNKNOWN

• Beijing Anzhen Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-11

Primary Completion

2022-11-23

Completion

2022-11-23

Countries

• China

Study Locations