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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfractionated heparin | Active Comparator | 70 units/kg body weight intravenous |
|
| bivalirudin | Active Comparator | intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unfractionated heparin | Drug | 70 units/kg body weight intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rod Stables, MA DM FRCP | Liverpool Heart and Chest Hospital, Liverpool, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | Merseyside | L14 3PE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25002178 | Derived | 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. | |
| 24219045 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unfractionated Heparin | 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unfractionated Heparin | 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of total participants | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unfractionated Heparin | 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rod Stables | Liverpool Heart and Chest Hospital | 01512281616 | 1489 | rod.stables@lhch.nhs.uk |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| C074619 | bivalirudin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Bivalirudin | Drug | intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour |
|
|
| 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 |
| Development of Thrombocytopenia | 28 days |
| Door-to-first Device Time | 28 days |
| Derived |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition | Posted | Number | percentage of total participants | 28 days |
|
|
|
| Secondary | CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure | Not Posted | 28 days |
| Secondary | Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition | Posted | Number | percentage of total participants | 28 days |
|
|
|
| Secondary | Stent Thrombosis Rate (ARC Definite or Probable) | Posted | Number | percentage of total participants | 28 days |
|
|
|
| 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 | Not Posted | 28 days |
| Secondary | All Cause Mortality | Not Posted | 1 year |
| Secondary | Development of Thrombocytopenia | Not Posted | 28 days |
| Secondary | Door-to-first Device Time | Not Posted | 28 days |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |