Current partner codePEPTIDESDE
NCT01519518·Phase 4·INTERVENTIONAL

How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Status

Completed

Phase

Phase 4

Enrollment

1,829

Locations

1

Results

Posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

unfractionated heparin

70 units/kg body weight intravenous

DRUG

Bivalirudin

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

Timeline

From registration to results.

  1. First posted

    Jan 27, 2012

  2. Study start

    Feb 2012

  3. Primary completion

    Dec 2013

  4. Study completion

    Dec 2013

  5. Results posted

    Apr 22, 2015

  6. Registry updated

    May 13, 2015

Outcomes

What the study measures.

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

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

Time frame · 28 days

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

Time frame · 28 days

Stent Thrombosis Rate (ARC Definite or Probable)

Time frame · 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

All Cause Mortality

Time frame · 1 year

Development of Thrombocytopenia

Time frame · 28 days

Door-to-first Device Time

Time frame · 28 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, United Kingdom

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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