How effective are two anti-clotting agents (heparin and bivalirudin) in the management of heart attack patients receiving Primary angioplasty (urgent procedure to restore blood flow to the heart by opening the blocked artery using small balloons and stents) treatment

HEAT-PPCI - How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention - A randomised controlled trial to compare unfractionated heparin versus bivalirudin in the treatment of patients with a clinical diagnosis of ST-segment elevation myocardial infarction, for planned management with primary PCI - How Effective are Antithrombotic Therapies in Primary PCI: HEATppci v1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005273-23-GB

Enrollment

1800

Registered

2011-12-12

Start date

2012-01-30

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST elevation myocardial infarction MedDRA version: 14.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Angiox Pharmaceutical Form: Powder for infusion INN or Proposed INN: Bivalirudin CAS Number: 128270-60-0 Other descriptive name: none Concentration unit: mg/ml milligram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting to participating centres with an ST elevation myocardial infarction event with PPCI as the proposed index reperfusion strategy Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900

Exclusion criteria

Exclusion criteria: • = 18 years of age • >12 hours since onset of severe pain • Known intolerance, hypersensitivity or contraindication to any trial medication • Active bleeding at presentation • Artificial ventilation, reduced conscious level or other factors precluding the administration of oral anti-platelet therapy • Previous enrolment in this trial

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 1) Peak CKMB release following index revascularisation measured with a single estimation 12-18 hours after the procedure 2) Minor bleeding: Type 1-2 bleeding according to BARC (Bleeding Academic Research Consortium) definition 3) Stent thrombosis rate (ARC definite or probable) ;Timepoint(s) of evaluation of this end point: 28 days	—

Primary

Measure	Time frame
Main Objective: Bivalirudin and heparin are two drugs used in heart attack patients to prevent blood clotting during treatment with Primary angioplasty. Primary angioplasty is an urgent treatment in heart attack patients required to restore blood flow to the heart by opening the blocked artery using small balloons and stents. The principal research question of our study is: Is there any difference in the efficacy and safety of the two study agents in the treatment of heart attack patients undergoing primary angioplasty?;Secondary Objective: Platelets are blood components that play a major role in clot formation. The clumping together of platelets in the blood is called platelet aggregation. The second question we want to ask is: Is there any difference between the two study drugs on their impact on platelet aggregation and other routine tests of clotting function in patients in this setting.;Primary end point(s): Primary Efficacy End Point: Major adverse cardiac events (MACE) in terms of the incidence of (a) All-cause mortality (b) Re-infarction (c) CVA (d) Additional unplanned target lesion revascularisation (TLR) Primary Safety End Point: Type 3-5 bleeding according to BARC (Bleeding Academic Research Consortium) definition;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: Bivalirudin and heparin are two drugs used in heart attack patients to prevent blood clotting during treatment with Primary angioplasty. Primary angioplasty is an urgent treatment in heart attack patients required to restore blood flow to the heart by opening the blocked artery using small balloons and stents. The principal research question of our study is: Is there any difference in the efficacy and safety of the two study agents in the treatment of heart attack patients undergoing primary angioplasty?;Secondary Objective: Platelets are blood components that play a major role in clot formation. The clumping together of platelets in the blood is called platelet aggregation. The second question we want to ask is: Is there any difference between the two study drugs on their impact on platelet aggregation and other routine tests of clotting function in patients in this setting.;Primary end point(s): Primary Efficacy End Point: Major adverse cardiac events (MACE) in terms of the incidence of (a) All-cause mortality (b) Re-infarction (c) CVA (d) Additional unplanned target lesion revascularisation (TLR) Primary Safety End Point: Type 3-5 bleeding according to BARC (Bleeding Academic Research Consortium) definition;Timepoint(s) of evaluation of this end point: 28 days

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Countries

United Kingdom

Contacts

Public ContactMargarita Perez-Casal

Liverpool Heart and Chest Hospital

Margarita.Perez-Casal@lhch.nhs.uk01516001467

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026