How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unfractionated heparin

70 units/kg body weight intravenous

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

70 units/kg body weight intravenous

bivalirudin

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

Group Type ACTIVE_COMPARATOR

Bivalirudin

Intervention Type DRUG

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

Interventions

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unfractionated heparin

70 units/kg body weight intravenous

Intervention Type DRUG

Bivalirudin

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

Intervention Type DRUG

Other Intervention Names

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UFH Angiox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No