How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Acute ST Elevation Myocardial Infarction Clinical Trial

— HEAT-PPCI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519518
• Other study ID #: 923
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: April 24, 2015
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1829
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute ST Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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		28 days	No
Primary	Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition		28 days	Yes
Secondary	CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure		28 days	No
Secondary	Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition		28 days	Yes
Secondary	Stent Thrombosis Rate (ARC Definite or Probable)		28 days	No
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		28 days	Yes
Secondary	All Cause Mortality		1 year	No
Secondary	Development of Thrombocytopenia		28 days	Yes
Secondary	Door-to-first Device Time		28 days	No