Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BJUHFRIGHT201802 | Other Identifier | Beijing United Heart Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anticoagulation | Experimental |
| |
| No anticoagulation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint - number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) | The number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) within 30 days after randomization | 30 days |
| Primary safety endpoint - The number of event of major bleeding | The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke | The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization | 30 days |
| Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32663660 | Background | Yan Y, Wang X, Guo J, Li Y, Ai H, Gong W, Que B, Zhen L, Lu J, Ma C, Montalescot G, Nie S. Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Am Heart J. 2020 Sep;227:19-30. doi: 10.1016/j.ahj.2020.06.005. Epub 2020 Jun 20. | |
| 42171583 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enoxaparin | Drug | 40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later |
|
| Unfractionated heparin | Drug | 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 |
|
| Bivalirudin placebo | Drug | Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later |
|
| Enoxaparin placebo syringe | Drug | 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. |
|
| Unfractionated heparin placebo | Drug | Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later. |
|
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization |
| 30 days |
| Secondary ischemic endpoints - The number of cardiovascular death events | The number of cardiovascular death event within 30 days after randomization | 30 days |
| Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events | The number of stent thrombosis (ARC definite) event within 30 days after randomization | 30 days |
| Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition) | The number of bleeding events (TIMI, STEEPLE and GUSTO definition) within 30 days after randomization To demonstrate that post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo is associated to lower rate of the composite endpoint of major bleeding according to TIMI, STEEPLE and GUSTO definitions within the first 30 days after randomization. | 30 days |
| Secondary safety endpoints - The number of thrombocytopenia events | The number of thrombocytopenia events within 30 days after randomization To demonstrate superiority of a strategy of post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo by the time from randomization to the first occurrence of any event of the Thrombocytopenia endpoint over 30 days of follow-up. | 30 days |
| Derived |
| Yan Y, Wang X, Fan Z, Guo J, Wang G, Yin D, Wang Z, Zhang F, Tian C, Gong W, Liu J, Lu J, Ma C, Vicaut E, Montalescot G, Nie S; RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention: 1-Year Results From the RIGHT Trial and Meta-analyses. JACC Asia. 2026 May 13:S2772-3747(26)00251-6. doi: 10.1016/j.jacasi.2026.04.003. Online ahead of print. |
| 38406848 | Derived | Yan Y, Guo J, Wang X, Wang G, Fan Z, Yin D, Wang Z, Zhang F, Tian C, Gong W, Liu J, Lu J, Li Y, Ma C, Vicaut E, Montalescot G, Nie S; RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial. Circulation. 2024 Apr 16;149(16):1258-1267. doi: 10.1161/CIRCULATIONAHA.123.067079. Epub 2024 Feb 26. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D017984 | Enoxaparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided