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

NCT07138508 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS188/2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

No Reflow Phenomenon; Anterior STEMI

Keywords

Nicorandil; No reflow; Anterior STEMI

Outcome Measures

Primary Outcomes (1)

• No reflow using angiographic criteria

  Incidence of No reflow

  Intra procedural

Secondary Outcomes (1)

• Major adverse cardiovascular events

  1 week from procedure

Study Arms (2)

Control

NO INTERVENTION

Has not received oral nicorandil

Treatment

ACTIVE COMPARATOR

Received 20mg of oral nicorandil

Drug: Nicorandil 20mg

Interventions

Nicorandil 20mg DRUG

Oral nicorandil 20mg

Treatment

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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr University for Science and Technology: collaborator

Study Sites (1)

Ain shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

No-Reflow Phenomenon

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome of the study was assessed by an interventional cardiologist blind to group allocation: Final TIMI Final MBG
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 24, 2025
• Study Start: March 10, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-07

Locations

EG (1)