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Completed

NCT Number: NCT01519518

How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

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.

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Key information

Conditions

Acute ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Unfractionated heparin

Drug

70 units/kg body weight intravenous

Other names: UFH

Bivalirudin

Drug

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

Other names: Angiox

Primary outcomes

  1. 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

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

    Time frame: 28 days

Secondary outcomes

  1. CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure

    Time frame: 28 days

  2. Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition

    Time frame: 28 days

  3. Stent Thrombosis Rate (ARC Definite or Probable)

    Time frame: 28 days

  4. 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

  5. All Cause Mortality

    Time frame: 1 year

  6. Development of Thrombocytopenia

    Time frame: 28 days

  7. Door-to-first Device Time

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: HEAT-PPCI

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2012
Registry last updated
May 13, 2015

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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