Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI

Ain Shams University

Status and phase

Completed

Phase 2

Phase 1

Conditions

No Reflow Phenomenon

Anterior STEMI

Treatments

Drug: Nicorandil 20mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07138508

FMASU MS188/2024

Details and patient eligibility

About

Aim of the study is to Investigate the potential role of oral nicorandil in preventing the No reflow phenomenon in anterior ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PPCI).

Assess whether nicorandil, a potassium channel activator, can effectively enhance myocardial perfusion in this specific clinical context.

In a randomized controlled trial study
All recruited patients were randomized to either the treatment or control group in a ratio of 1:1 using a computer-generated randomization sequence in relation to the order of participation in the study. Patients fulfilling the inclusion criteria and consenting to participate in the study were recruited.

Full description

This is a randomized, controlled clinical trial designed to evaluate the efficacy of a single oral dose of nicorandil in preventing the no-reflow phenomenon in patients with anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Study Setting:

The study is conducted at the Cardiology Departments of Ain Shams University Hospitals and Misr University for Science and Technology Hospitals.

Study intervention:

Group A (Study Group): Receives a single oral dose of nicorandil 20 mg prior to PPCI.

Group B (Control Group):Undergoes PPCI without receiving nicorandil.

Randomization and Sampling:

Patients meeting the inclusion criteria and providing informed consent are randomized using a computer-generated sequence to ensure unbiased allocation. A total of 300 patients enrolled, with 150 patients per group.

Ethical Considerations:

Ethical approval has been obtained from the Ethical Committee Board of Ain Shams University, and the study is conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent is obtained from all participants either in the emergency department or catheterization laboratory prior to the intervention.

Study Procedures:

All enrolled patients undergo:

Comprehensive Clinical Evaluation:

Detailed history with emphasis on coronary artery disease (CAD) risk factors:

Age
Sex
Diabetes Mellitus (DM)
Hypertension (HTN)
Family history of ischemic heart disease (IHD)
Dyslipidemia
Chronic kidney disease (CKD)
Smoking status
Clinical presentation and functional status using the Killip classification.
Vital signs monitoring.

Electrocardiogram (ECG):

Standard 12-lead ECG obtained on first medical contact to confirm STEMI diagnosis.

All PCI procedures are performed by experienced interventional cardiologists using standardized protocols for anterior STEMI intervention.

Data Collection and Assessments:

Angiographic Data:

TIMI flow grade is assessed post-PCI by two independent interventional cardiologists blinded to treatment allocation to objectively evaluate coronary flow.

Echocardiographic Assessment:

Transthoracic echocardiography (TTE) is performed after PCI and prior to hospital discharge.

Left ventricular ejection fraction (LVEF) is measured using the modified Simpson's method by an independent echocardiographer blinded to group allocation.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years
Patients diagnosed with anterior ST-segment elevation myocardial infarction (STEMI).
Individuals scheduled for percutaneous coronary intervention (PPCI).
Presence of risk factors or indications for preventing the No reflow phenomenon.
Willingness and ability to comply with the study protocol.
Ability to provide informed consent for participation in the study.

Exclusion criteria

Known allergic reaction to oral nicorandil.
Concomitant use of medications that may interact with nicorandil.
Presence of contraindications to oral nicorandil such as hypotension, hepatic or renal impairment
Need for emergent coronary artery bypass grafting.