Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

NCT ID: NCT05247424

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2025-03-05

Brief Summary

Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention.

Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.

Detailed Description

Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight.

The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality.

Investigators plan to randomize 600 patients.

Conditions

STEMI - ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early unfractionated heparin

Administration of UFH at a dose of 100 IU/kg body weight at first medical contact. Addition of UFH before coronary intervention according to ACT measurement after coronary angiography before coronary intervention.

Group Type: EXPERIMENTAL

Unfractionated heparin

Intervention Type: DRUG

Unfractionated heparin at dose of 100 IU /kg body weight

Control - Unfractionated heparin for coronary intervention only

Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Unfractionated heparin

Unfractionated heparin at dose of 100 IU /kg body weight

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients with STEMI referred for primary PCI
• Duration of symptoms less than 6 hours before presentation

Exclusion Criteria

• Pregnancy
• Cardiogenic shock at presentation (hemodynamic instability)
• Cardiac arrest before randomization
• Duration of symptoms for more than 6 hours before presentation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Peter Radsel

Head of intensive internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miša Fister, MD, PhD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

UMC Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

Heparin-STEMI

Identifier Type: -

Identifier Source: org_study_id