Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction (UFH-STEMI)

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Unfractionated heparin

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Miša Fister, MD, PhD; Phone Number: +38615229825; Email: misa.fister@gmail.com
• Study Contact Backup: Name: Tomaz Goslar, MD, PhD; Phone Number: +38615229825; Email: tomaz.goslar@gmail.com

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • UMC Ljubljana
    • Contact: Tomaž Goslar, MD; Phone Number: +38615229532; Email: tomaz.goslar@ukclj.si
    • Contact: Misa Fister, MD; Phone Number: +38615229599; Email: misa.fister@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Unfractionated heparin; Unfractionated heparin at dose of 100 IU /kg body weight
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIMI flow	TIMI flow in culprit coronary artery at first coronary angiography	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Bleeding assessed by Bleeding Academic Research Consortium (BARC) score. BARC incorporates 5 bleeding types, ranging from BARC 0 - no bleeding to BARC 5 - fatal bleeding.	Day 0
Cardiogenic shock	Presence of cardiogenic shock at any time after randomization	Day 0 to 10
30 day mortality after STEMI	30-day mortality after STEMI	30 days
Troponin I concentration 24 h after primary PCI	Troponin I concentration 24 h after primary PCI	24 h

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Miša Fister, MD, PhD, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial Reperfusion; pre-treatment; Unfractionated heparin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: Heparin-STEMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No