Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

NCT05247424 | Completed Phase 4

• 1 other identifier: Heparin-STEMI
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Myocardial Reperfusion; Unfractionated heparin; pre-treatment

Outcome Measures

Primary Outcomes (1)

• TIMI flow

  TIMI flow in culprit coronary artery at first coronary angiography

  Day 0

Secondary Outcomes (4)

• Bleeding

  Day 0

• Cardiogenic shock

  Day 0 to 10

• 30 day mortality after STEMI

  30 days

• Troponin I concentration 24 h after primary PCI

  24 h

Study Arms (2)

Early unfractionated heparin

EXPERIMENTAL

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.

Drug: Unfractionated heparin

Control - Unfractionated heparin for coronary intervention only

NO INTERVENTION

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

Interventions

Unfractionated heparin DRUG

Unfractionated heparin at dose of 100 IU /kg body weight

Early unfractionated heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Miša Fister, MD, PhD

  UMC Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interventional cardiologists evaluating coronary angiography will be blinded to assigned group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of intensive internal medicine department

Model Details: randomization in 1:1 ratio

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 18, 2022
• Study Start: March 10, 2022
• Primary Completion: February 5, 2025
• Study Completion: March 5, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

SL (1)