NCT03664180

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

Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,989 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-11
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2018-09-10
• Last updated: 2023-05-03

Locations

1 site across 1 country: China