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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Rod Stables, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01519518
First received: January 24, 2012
Last updated: December 18, 2013
Last verified: December 2013

January 24, 2012
December 18, 2013
February 2012
December 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Type 3-5 bleeding according to BARC (Bleeding Academic Research Consortium)definition [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01519518 on ClinicalTrials.gov Archive Site
  • CKMB release following index revascularisation measured with a single estimation 12-18 hours after the procedure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Minor bleeding: Type 2 bleeding according to BARC (Bleeding Academic Research Consortium) definition [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rate (ARC definite or probable) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Development of thrombocytopenia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Door-to-first device time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Peak CKMB release following index revascularisation measured with a single estimation 12-18 hours after the procedure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Minor bleeding: Type 1-2 bleeding according to BARC (Bleeding Academic Research Consortium) definition [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rate (ARC definite or probable) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute ST Elevation Myocardial Infarction
  • 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
  • Active Comparator: Unfractionated heparin
    70 units/kg body weight intravenous
    Intervention: Drug: unfractionated heparin
  • Active Comparator: bivalirudin
    intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
    Intervention: Drug: Bivalirudin
Malik N, Gershlick AH. The clinical and economic impact of bivalirudin for percutaneous coronary intervention. Expert Rev Pharmacoecon Outcomes Res. 2013 Dec;13(6):699-706. doi: 10.1586/14737167.2013.844650.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1830
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01519518
923
Yes
Dr Rod Stables, Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Not Provided
Principal Investigator: Rod Stables, MA DM FRCP Liverpool Heart and Chest Hospital, Liverpool, UK
Liverpool Heart and Chest Hospital NHS Foundation Trust
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP