No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track

NCT06966674 | Recruiting

• 1 other identifier: KFSIRB200-587
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the no-reflow in patients with STEMI after intracoronary glycoprotein IIb/IIIa inhibitors after opening of track in thrombus.

Conditions

No-Reflow; STEMI; Intracoronary; Tirofiban

Outcome Measures

Primary Outcomes (1)

• Blood stream

  Blood stream in coronary artery before and after treatment, including Thrombolysis in Myocardial Infarction (TIMI) flow grade in IRAs, coronary blood flow will be calculated with TIMI frame count method.

  After treatment (Up to 15 minutes)

Secondary Outcomes (1)

• Incidence of major adverse cardiac events

  After treatment (Up to 30 days)

Study Arms (2)

Intracoronary tirofiban group

EXPERIMENTAL

Patients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg)

Drug: Intracoronary tirofiban

Control group

PLACEBO COMPARATOR

Patients will receive intracoronary saline 0.9% solution as a control group.

Drug: Saline 0.9%

Interventions

Intracoronary tirofiban DRUG

Patients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg).

Also known as: Aggrastat

Intracoronary tirofiban group

Saline 0.9% DRUG

Patients will receive intracoronary saline 0.9% solution as a control group.

Control group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Both sexes.
• Patients with STEMI. ST-segment elevated myocardial infarction is defined as typical chest pain \>30 minutes with ST-segment elevation of \>1 mm in at least 2 consecutive leads on the electrocardiogram or new-onset left bundle brunch block.

You may not qualify if:

• Treatment with thrombolytic drugs in the previous 24 hours.
• Known malignancy.
• Thrombocytopenia.
• End-stage liver disease.
• Cardiogenic shock.
• Renal failure with glomerular filtration\<30 ml/min.
• Contraindication for the use of tirofiban.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tirofiban; Sodium Chloride

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)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mohammed A Hammad, MD

CONTACT

00201015928694; drhammad879@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: May 12, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)