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Clinical Trials/NCT01519518
NCT01519518CompletedPhase 4

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 Events - For Planned Management With Primary PCI

Liverpool Heart and Chest Hospital NHS Foundation Trust1 site in 1 country1,829 target enrollmentStarted: February 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
1,829
Locations
1
Primary Endpoint
Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization

Study Overview

Brief Summary

The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.

Detailed Description

HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).

Pre-Specified Subgroup Analyses

  • Subgroup analyses looking at the impact of access site comparing radial versus femoral route
  • Assessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients
  • Comparing the outcomes in patients < or ≥ 75 years of age
  • Type of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)
  • Patients with impaired LV function versus normal LV function
  • Patients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted

PLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial

Exclusion Criteria

  • ≤ 18 years of age
  • 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 antiplatelet therapy
  • Previous enrolment in this trial

Arms & Interventions

Unfractionated heparin

Active Comparator

70 units/kg body weight intravenous

Intervention: unfractionated heparin (Drug)

bivalirudin

Active Comparator

intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Intervention: Bivalirudin (Drug)

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization

Time Frame: 28 days

Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition

Time Frame: 28 days

Secondary Outcomes

  • All Cause Mortality(1 year)
  • CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure(28 days)
  • Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition(28 days)
  • Stent Thrombosis Rate (ARC Definite or Probable)(28 days)
  • For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes(28 days)
  • Development of Thrombocytopenia(28 days)
  • Door-to-first Device Time(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Rod Stables

Consultant Cardiologist

Liverpool Heart and Chest Hospital NHS Foundation Trust

Study Sites (1)

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