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: April 24, 2015
Last verified: April 2015
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute ST Elevation Myocardial Infarction
Interventions: Drug: unfractionated heparin
Drug: Bivalirudin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Unfractionated Heparin

70 units/kg body weight intravenous

unfractionated heparin: 70 units/kg body weight intravenous

Bivalirudin

intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour


Participant Flow:   Overall Study
    Unfractionated Heparin     Bivalirudin  
STARTED     914     915  
COMPLETED     907     905  
NOT COMPLETED     7     10  
Consent not available                 7                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Unfractionated Heparin

70 units/kg body weight intravenous

unfractionated heparin: 70 units/kg body weight intravenous

Bivalirudin

intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Total Total of all reporting groups

Baseline Measures
    Unfractionated Heparin     Bivalirudin     Total  
Number of Participants  
[units: participants]
  907     905     1812  
Age  
[units: years]
Median (Inter-Quartile Range)
  63.6   (54.0 to 73.8)     62.9   (53.7 to 74)     63.2   (53.9 to 73.9)  
Gender  
[units: participants]
     
Female     244     258     502  
Male     663     647     1310  



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

3.  Secondary:   Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition   [ Time Frame: 28 days ]

4.  Secondary:   Stent Thrombosis Rate (ARC Definite or Probable)   [ Time Frame: 28 days ]

5.  Secondary:   CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   All Cause Mortality   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Development of Thrombocytopenia   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Door-to-first Device Time   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Rod Stables
Organization: Liverpool Heart and Chest Hospital
phone: 01512281616 ext 1489
e-mail: rod.stables@lhch.nhs.uk


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

Publications automatically indexed to this study:

Responsible Party: Dr Rod Stables, 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
Results First Received: April 7, 2015
Last Updated: April 24, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency