Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

NCT04475835 | Unknown

• 1 other identifier: XJTU1AF2020LSK-017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI With Multivessel Coronary Disease

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical events (NACE)

  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

  30 days

Secondary Outcomes (7)

• Major adverse cardiac and cerebral events (MACE)

  30 days

• Major adverse cardiac and cerebral events (MACE)

  6 months

• Bleeding

  30 days

• Bleeding

  6 months

• Stent thrombosis

  Hospitalization

Study Arms (2)

Bivalirudin

EXPERIMENTAL

Bivalirudin with prolonged full dose infusion during PCI

Drug: Bivalirudin

Heparin

ACTIVE COMPARATOR

Heparin 100U/kg

Drug: Heparin

Interventions

Bivalirudin DRUG

Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.

Bivalirudin

Heparin DRUG

Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of heparin should be administered by need.

Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new left bundle branch block.
• Staged intervention of non-infarction related artery within 5 days after PPCI during Hospitalization.
• Signed informed consent.

You may not qualify if:

• Cardiogenic shock.
• Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before randomized.
• Active bleeding, recent bleeding events or bleeding tendency.
• History of surgery in the last 1 month.
• Suspicious symptoms of aortic dissection, pericarditis and endocarditis.
• Blood pressure \> 180/110 mmHg.
• Hemoglobin \< 100 g/L, Platelet count \<100×10(9)/L, Transaminase 3 times upper limit of normality or Creatinine clearance \<30ml/min.
• History of Heparin-Induced Thrombocytopenia.
• Allergic to any research drug or device.
• Pregnancy or lactation.
• Any condition that makes the patient unsuitable for PCI or may interfere with the study.
• Patient disagrees or fails to sign the written informed consent.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Interventions

bivalirudin; Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yihui Xiao

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Xiao

CONTACT

+86-18220824850; sbw_514@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: January 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (1)