How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
HEAT-PPCI
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
1 other identifier
interventional
1,829
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 22, 2015
CompletedMay 13, 2015
April 1, 2015
1.8 years
January 24, 2012
April 7, 2015
April 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization
28 days
Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition
28 days
Secondary Outcomes (7)
CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure
28 days
Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition
28 days
Stent Thrombosis Rate (ARC Definite or Probable)
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
28 days
All Cause Mortality
1 year
- +2 more secondary outcomes
Study Arms (2)
Unfractionated heparin
ACTIVE COMPARATOR70 units/kg body weight intravenous
bivalirudin
ACTIVE COMPARATORintravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Interventions
70 units/kg body weight intravenous
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Eligibility Criteria
You may qualify if:
- All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial
You may not qualify if:
- ≤ 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, L14 3PE, United Kingdom
Related Publications (2)
Shahzad A, Kemp I, Mars C, Wilson K, Roome C, Cooper R, Andron M, Appleby C, Fisher M, Khand A, Kunadian B, Mills JD, Morris JL, Morrison WL, Munir S, Palmer ND, Perry RA, Ramsdale DR, Velavan P, Stables RH; HEAT-PPCI trial investigators. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014 Nov 22;384(9957):1849-1858. doi: 10.1016/S0140-6736(14)60924-7. Epub 2014 Jul 4.
PMID: 25002178DERIVEDMalik 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.
PMID: 24219045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Rod Stables
- Organization
- Liverpool Heart and Chest Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Rod Stables, MA DM FRCP
Liverpool Heart and Chest Hospital, Liverpool, UK
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Cardiologist
Study Record Dates
First Submitted
January 24, 2012
First Posted
January 27, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 13, 2015
Results First Posted
April 22, 2015
Record last verified: 2015-04