drugset / Trial / NCT03664180

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

NCT03664180 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-01-11
Primary completion
2022-11-23
Completion
2022-11-23

Outcome

Missed primary endpoint

paper The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). PMID 38406848 ↗

paper Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events. PMID 38406848 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 0.2 mg/kg Intravenous
Subject Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Subject HEPARIN CALCIUM Other / unclassified 10 iu/kg Intravenous