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
  Purpose

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.


Condition Intervention Phase
Acute ST Elevation Myocardial Infarction
Drug: unfractionated heparin
Drug: Bivalirudin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1830
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unfractionated heparin
70 units/kg body weight intravenous
Drug: unfractionated heparin
70 units/kg body weight intravenous
Active Comparator: bivalirudin
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Drug: Bivalirudin
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519518

Locations
United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom, L14 3PE
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
Principal Investigator: Rod Stables, MA DM FRCP Liverpool Heart and Chest Hospital, Liverpool, UK
  More Information

No publications provided by Liverpool Heart and Chest Hospital NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rod Stables, Consultant Cardiologist, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01519518     History of Changes
Other Study ID Numbers: 923
Study First Received: January 24, 2012
Last Updated: December 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
ST elevation myocardial infarction
Primary percutaneous coronary intervention
Unfractionated heparin
Bivalirudin
primary angioplasty

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Bivalirudin
Heparin
Hirudins
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014