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NCT04475835
Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention
NA trial testing Bivalirudin in STEMI With Multivessel Coronary Disease in 100 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | First Affiliated Hospital Xi'an Jiaotong University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 12 January 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bivalirudin (BIVALIRUDIN) — full drug profile →
- Heparin (HEPARIN) — full drug profile →
Conditions studied
- STEMI With Multivessel Coronary Disease — all drugs for STEMI With Multivessel Coronary Disease →
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Who can join
18 and older, any sex, with STEMI With Multivessel Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Net adverse clinical events (NACE)
Time frame: 30 days
A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5). BARC=Bleeding Academic Research Consortium
Sponsor's own description
This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention. NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04475835
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bivalirudin
Trials testing the same drug.
- NCT05959252 — BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation · Phase 2 · recruiting
- NCT05984537 — A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation. · Phase 4 · recruiting
- NCT05334654 — Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients · NA · completed
- NCT04195997 — Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion · Phase 4 · unknown
- NCT04185077 — Bivalirudin in Late PCI for Oatients With STEMI · Phase 4 · unknown
Other First Affiliated Hospital Xi'an Jiaotong University trials
Trials by the same sponsor.
- NCT07389460 — Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) · Phase 3 · not yet recruiting
- NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine · NA · recruiting
- NCT07168291 — Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma · EARLY_PHASE1 · not yet recruiting
- NCT06775782 — Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis · NA · recruiting
- NCT07266467 — Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Dis · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04475835 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital Xi'an Jiaotong University
- Last refreshed: 26 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04475835.
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