DRUG
unfractionated heparin
70 units/kg body weight intravenous
Status
Completed
Phase
Phase 4
Enrollment
1,829
Locations
1
Results
Posted
Publications
2
Study 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.
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
DRUG
70 units/kg body weight intravenous
DRUG
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Timeline
First posted
Jan 27, 2012
Study start
Feb 2012
Primary completion
Dec 2013
Study completion
Dec 2013
Results posted
Apr 22, 2015
Registry updated
May 13, 2015
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
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
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
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
Publications
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