Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— UFH-STEMI  

Official title:

Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247424
• Other study ID #: Heparin-STEMI
• Status: Recruiting
• Phase: Phase 4
• Start date: March 10, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: University Medical Centre Ljubljana
• Contact: Miša Fister, MD, PhD
• Phone: +38615229825
• Email: misa.fister[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Drug:
• Unfractionated heparin
Unfractionated heparin at dose of 100 IU /kg body weight

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI flow	TIMI flow in culprit coronary artery at first coronary angiography	Day 0
Secondary	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
Secondary	Cardiogenic shock	Presence of cardiogenic shock at any time after randomization	Day 0 to 10
Secondary	30 day mortality after STEMI	30-day mortality after STEMI	30 days
Secondary	Troponin I concentration 24 h after primary PCI	Troponin I concentration 24 h after primary PCI	24 h