How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention (HEAT-PPCI)

April 24, 2015 updated by: Dr Rod Stables, Liverpool Heart and Chest Hospital NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1829

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unfractionated heparin
70 units/kg body weight intravenous
Drug: unfractionated heparin
70 units/kg body weight intravenous
Other Names:
  • UFH
Active Comparator: bivalirudin
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Drug: Bivalirudin
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Other Names:
  • Angiox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days
Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All Cause Mortality
Time Frame: 1 year
1 year
CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure
Time Frame: 28 days
28 days
Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition
Time Frame: 28 days
28 days
Stent Thrombosis Rate (ARC Definite or Probable)
Time Frame: 28 days
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
Time Frame: 28 days
28 days
Development of Thrombocytopenia
Time Frame: 28 days
28 days
Door-to-first Device Time
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Rod Stables, MA DM FRCP, Liverpool Heart and Chest Hospital, Liverpool, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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