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Completed

NCT Number: NCT05247424

Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

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.

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfractionated heparin

Drug

Unfractionated heparin at dose of 100 IU /kg body weight

Primary outcomes

  1. TIMI flow

    Time frame: Day 0

    TIMI flow in culprit coronary artery at first coronary angiography

Secondary outcomes

  1. Bleeding

    Time frame: Day 0

    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.

  2. Cardiogenic shock

    Time frame: Day 0 to 10

    Presence of cardiogenic shock at any time after randomization

  3. 30 day mortality after STEMI

    Time frame: 30 days

    30-day mortality after STEMI

  4. Troponin I concentration 24 h after primary PCI

    Time frame: 24 h

    Troponin I concentration 24 h after primary PCI

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: UFH-STEMI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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