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Completed

NCT Number: NCT03822975

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bengbu Second People's Hospital, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any age;
  • STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
  • Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
  • Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
  • The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion criteria

  • Not suitable for emergency primary PCI;
  • STEMI treated by thrombolysis;
  • Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
  • Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
  • Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
  • Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).

Treatment and study plan

Bivalirudin

Drug

Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.

Unfractionated heparin

Drug

Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.

Primary outcomes

  1. Composite of all-cause death or BARC type 3~5 bleeding

    Time frame: 30 days

    BARC=Bleeding academic research consortium

Secondary outcomes

  1. All cause mortality

    Time frame: 30 days

  2. BARC type 3-5 bleeding

    Time frame: 30 days

    BARC=Bleeding academic research consortium

  3. Major adverse cardiac and cerebral events (MACE)

    Time frame: 30 days

    MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization

  4. Net adverse clinical events (NACE)

    Time frame: 30 days

    NACE is defined as a composite of MACE or BARC type 3-5 bleeding

  5. Composite of all-cause death or BARC type 2-5 bleeding

    Time frame: 30 days

    BARC=Bleeding academic research consortium

  6. BARC type 2-5 bleeding

    Time frame: 30 days

    BARC=Bleeding academic research consortium

  7. Stent thrombosis

    Time frame: 30 days

    Definite or probable stent thrombosis according to Academic Research Consortium

  8. Thrombocytopenia

    Time frame: 30 days

    defined as platelet counts less than 150*10^9/L after treatment

  9. All cause mortality

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

Acronym: BRIGHT-4

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 30, 2019
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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