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

NCT ID: NCT06966674

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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ST-segment-elevation myocardial infarction (STEMI) is most commonly caused by rupture or erosion of an atherosclerotic plaque, resulting in acute occlusion of the coronary artery, and the preferred reperfusion strategy is primary percutaneous coronary intervention (PCI).

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients STEMI.

In recent years, mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI.

Conditions

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No-Reflow STEMI Intracoronary Tirofiban

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intracoronary tirofiban group

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

Group Type EXPERIMENTAL

Intracoronary tirofiban

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type DRUG

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

Interventions

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Intracoronary tirofiban

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

Intervention Type DRUG

Saline 0.9%

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

Intervention Type DRUG

Other Intervention Names

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Aggrastat

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Ali Mohammed Hammad

Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed A Hammad, MD

Role: CONTACT

00201015928694

Facility Contacts

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Mohammed A Hammad, MD

Role: primary

00201015928694

Other Identifiers

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KFSIRB200-587

Identifier Type: -

Identifier Source: org_study_id

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