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Trial record 70 of 172 for:    "Heart Disease" | "Heparin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519518
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 22, 2015
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Dr Rod Stables, Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Acute ST Elevation Myocardial Infarction Drug: unfractionated heparin Drug: Bivalirudin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Unfractionated heparin
70 units/kg body weight intravenous
Drug: unfractionated heparin
70 units/kg body weight intravenous
Other Name: UFH

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
Other Name: Angiox

Primary Outcome Measures :
  1. 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 ]
  2. Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure [ Time Frame: 28 days ]
  2. Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition [ Time Frame: 28 days ]
  3. Stent Thrombosis Rate (ARC Definite or Probable) [ Time Frame: 28 days ]
  4. 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 ]
  5. All Cause Mortality [ Time Frame: 1 year ]
  6. Development of Thrombocytopenia [ Time Frame: 28 days ]
  7. Door-to-first Device Time [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519518

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Rod Stables, Consultant Cardiologist, Liverpool Heart and Chest Hospital NHS Foundation Trust Identifier: NCT01519518     History of Changes
Other Study ID Numbers: 923
First Posted: January 27, 2012    Key Record Dates
Results First Posted: April 22, 2015
Last Update Posted: May 13, 2015
Last Verified: April 2015
Keywords provided by Dr Rod Stables, Liverpool Heart and Chest Hospital NHS Foundation Trust:
ST elevation myocardial infarction
Primary percutaneous coronary intervention
Unfractionated heparin
primary angioplasty
Additional relevant MeSH terms:
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Heart Diseases
Calcium heparin
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors