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

NCT ID: NCT07138508

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-10
• Study Completion Date: 2025-03-01

Brief Summary

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.

Detailed 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.

Conditions

No Reflow Phenomenon; Anterior STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Has not received oral nicorandil

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

Received 20mg of oral nicorandil

Group Type: ACTIVE_COMPARATOR

Nicorandil 20mg

Intervention Type: DRUG

Oral nicorandil 20mg

Interventions

Nicorandil 20mg

Oral nicorandil 20mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain shams University hospitals

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

FMASU MS188/2024

Identifier Type: -

Identifier Source: org_study_id