STEMI - ST Elevation Myocardial InfarctionPhase 4RIGHTNCT03664180
Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI
A Phase 4 study testing Bivalirudin, Enoxaparin and Unfractionated heparin in people with STEMI - ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Bivalirudin, Enoxaparin and Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,989 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2019to 23 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- STEMI with PPCI of culprit lesion
- Bivalirudin therapy during PPCI
- Signed informed consent form
Who cannot join
- Patients with a formal indication for anticoagulation after PPCI (e.g. atrial fibrillation, left-ventricular thrombus, intra-aortic balloon pump, pulmonary embolism, mechanical heart valve)
- Patients with any indication for chronic anticoagulation
- Patient with previous lytic treatment
- Patient with previous coronary artery bypass graft surgery
- Cardiogenic shock, malignant ventricular arrhythmia, or mechanical complications
- Any anticoagulation other than bivalirudin started after the procedure before randomization
Show all 19Show fewer
- Estimated body weight of >120 kg or <45kg
- BP ≥180/110mmHg at randomization
- Any bleeding diathesis or severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (<6months) ischemic stroke or TIA, recent (<6months) intracranial hemorrhage or, gastrointestinal or genitourinary bleeding within the past 2 weeks
- History of heparin-induced thrombocytopenia
- Suspected acute aortic dissection (AAD)
- Major surgery within 1 month
- A planned elective surgical procedure that would necessitate an interruption in treatment with P2Y12 inhibitors in the next 6 months after enrollment
- Known PLT≤100×109 or HGB≤10g/L
- Known transaminase >3-fold ULN, or CCr<30ml/min
- Known allergy to any study drug
- Pregnancy or lactation
- Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
- Current participation in an investigational drug or device trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Bivalirudin, Enoxaparin, Unfractionated heparin, Bivalirudin placebo, Enoxaparin placebo syringe
- Keywords
- anticoagulantion, post-procedure, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
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
EnoxaparinDrug
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
Unfractionated heparinDrug
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 placeboDrug
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
Enoxaparin placebo syringeDrug
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 placeboDrug
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
| Study group | Role | What they receive |
|---|---|---|
| anticoagulation | Experimental | Not described Receives: Drug: Bivalirudin; Drug: Enoxaparin; Drug: Unfractionated heparin |
| No anticoagulation | Placebo comparator | Not described Receives: Drug: Bivalirudin placebo; Drug: Enoxaparin placebo syringe; Drug: Unfractionated heparin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Secondary outcomes (6)
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
Measured: 30 days
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
Measured: 30 days
Secondary ischemic endpoints - The number of cardiovascular death events
The number of cardiovascular death event within 30 days after randomization
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start11 Jan 2019
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664180
- Sponsor's protocol ID
- 2018024X
- Other IDs
- BJUHFRIGHT201802
- Acronym
- RIGHT
- Status last verified
- Apr 2023
- First submitted
- 27 Aug 2018
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32663660Yan 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 Jul;6(7):1095-1105. doi: 10.1016/j.jacasi.2026.04.003. Epub 2026 May 22.
PubMed 42171583Yan 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.
PubMed 38406848
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03664180
- Acronym / sponsor ID
- RIGHT / 2018024X
- Keywords
- anticoagulantion, post-procedure, STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,989 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Groupe Hospitalier Pitie-Salpetriere
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticoagulation | Experimental | Drug: Bivalirudin, Drug: Enoxaparin, Drug: Unfractionated heparin |
| No anticoagulation | Placebo comparator | Drug: Bivalirudin placebo, Drug: Enoxaparin placebo syringe, Drug: Unfractionated heparin placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- STEMI with PPCI of culprit lesion
- Bivalirudin therapy during PPCI
- Signed informed consent form
Key exclusion criteria (19 listed)
- Patients with a formal indication for anticoagulation after PPCI (e.g. atrial fibrillation, left-ventricular thrombus, intra-aortic balloon pump, pulmonary embolism, mechanical heart valve)
- Patients with any indication for chronic anticoagulation
- Patient with previous lytic treatment
- Patient with previous coronary artery bypass graft surgery
- Cardiogenic shock, malignant ventricular arrhythmia, or mechanical complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BivalirudinIV 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 | anticoagulation |
| Enoxaparin40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later | Drug | anticoagulation |
| Unfractionated heparinIV 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 | anticoagulation |
| Bivalirudin placeboMatching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later | Drug | No anticoagulation |
| Enoxaparin placebo syringePlacebo 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 | No anticoagulation |
| Unfractionated heparin placeboMatching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later. | Drug | No anticoagulation |
Primary outcome
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)
Time frame: 30 days
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
Primary safety endpoint - The number of event of major bleeding
Time frame: 30 days
The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
6 secondary outcomes
Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time frame: 30 days
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
Time frame: 30 days
Secondary ischemic endpoints - The number of cardiovascular death events
Time frame: 30 days
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
Time frame: 30 days
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
Time frame: 30 days
Secondary safety endpoints - The number of thrombocytopenia events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 32663660Yan 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.
- Derived from this study: PubMed 42171583Yan 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 Jul;6(7):1095-1105. doi: 10.1016/j.jacasi.2026.04.003. Epub 2026 May 22.
- Derived from this study: PubMed 38406848Yan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin, Enoxaparin and Unfractionated heparin in people with STEMI - ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664180, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.