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

PHASE4CompletedINTERVENTIONAL
Enrollment

2,989

Participants

Timeline

Start Date

January 11, 2019

Primary Completion Date

November 23, 2022

Study Completion Date

November 23, 2022

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.

Trial Locations (1)

100029

Beijing Anzhen Hospital, Capital Medical University, Beijing

All Listed Sponsors
collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

collaborator

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

UNKNOWN

lead

Beijing Anzhen Hospital

OTHER

NCT03664180 - Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI | Biotech Hunter | Biotech Hunter