No Reflow PhenomenonPhase 1/2NCT07138508
Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI
A Phase 1/2 study testing Nicorandil 20mg in people with No Reflow Phenomenon and Anterior STEMI, run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Reflow Phenomenon, Anterior STEMI
- What is being tested?
- Nicorandil 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 1 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Nicorandil 20mg
- Keywords
- Nicorandil, No reflow, Anterior STEMI
- Medical subject headings
- No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 20mgDrug
Oral nicorandil 20mg
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Has not received oral nicorandil |
| Treatment | Active comparator | Received 20mg of oral nicorandil Receives: Drug: Nicorandil 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
No reflow using angiographic criteria
Incidence of No reflow
Measured: Intra procedural
Secondary outcomes (1)
Major adverse cardiovascular events
Incident of stroke, reinfarction, arrhythmia and cardiac arrest were recorded
Measured: 1 week from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 Mar 2024
- Primary completion28 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Reflow PhenomenonStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138508
- Sponsor's protocol ID
- FMASU MS188/2024
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD data will shared after obtaining publication acceptance
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI
- ClinicalTrials.gov ID
- NCT07138508
- Acronym / sponsor ID
- FMASU MS188/2024
- Conditions
- No Reflow Phenomenon, Anterior STEMI
- Keywords
- Nicorandil, No reflow, Anterior STEMI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Has not received oral nicorandil |
| Treatment | Active comparator | Drug: Nicorandil 20mgReceived 20mg of oral nicorandil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicorandil 20mgOral nicorandil 20mg | Drug | Treatment |
Primary outcome
No reflow using angiographic criteria
Time frame: Intra procedural
Incidence of No reflow
1 secondary outcome
Major adverse cardiovascular events
Time frame: 1 week from procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided. IPD data will shared after obtaining publication acceptance
Related trials for No Reflow Phenomenon
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A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
No-Reflow Phenomenon, Coronary Artery Disease
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Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
STEMI, No-Reflow Phenomenon
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Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nicorandil 20mg in people with No Reflow Phenomenon and Anterior STEMI, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No reflow using angiographic criteria (time frame: Intra procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.