No-ReflowNCT06966674
No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track
A study testing Intracoronary tirofiban and Saline 0.9% in people with No-Reflow and STEMI, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to assess the no-reflow in patients with STEMI after intracoronary glycoprotein IIb/IIIa inhibitors after opening of track in thrombus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No-Reflow, STEMI, Intracoronary
- What is being tested?
- Intracoronary tirofiban and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Mohammed A Hammad, MD, 00201015928694, drhammad879@gmail.com
Wael A Hassib, MD
About this study
Official title: Assessment of No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track
This study aims to assess the no-reflow in patients with STEMI after intracoronary glycoprotein IIb/IIIa inhibitors after opening of track in thrombus.
Read the detailed description
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
- No-Reflow, STEMI, Intracoronary, Tirofiban
- Being tested
- Intracoronary tirofiban, Saline 0.9%
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary tirofibanDrug
Also called Aggrastat
Patients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg).
Saline 0.9%Drug
Patients will receive intracoronary saline 0.9% solution as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary tirofiban group | Experimental | Patients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg) Receives: Drug: Intracoronary tirofiban |
| Control group | Placebo comparator | Patients will receive intracoronary saline 0.9% solution as a control group. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood stream
Blood stream in coronary artery before and after treatment, including Thrombolysis in Myocardial Infarction (TIMI) flow grade in IRAs, coronary blood flow will be calculated with TIMI frame count method.
Measured: After treatment (Up to 15 minutes)
Secondary outcomes (1)
Incidence of major adverse cardiac events
Incidence of major adverse cardiac events were recorded.
Measured: After treatment (Up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start12 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No-ReflowStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Mohammed Hammad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966674
- Sponsor's protocol ID
- KFSIRB200-587
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track
- ClinicalTrials.gov ID
- NCT06966674
- Acronym / sponsor ID
- KFSIRB200-587
- Conditions
- No-Reflow, STEMI, Intracoronary, Tirofiban
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 May 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary tirofiban group | Experimental | Drug: Intracoronary tirofibanPatients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg) |
| Control group | Placebo comparator | Drug: Saline 0.9%Patients will receive intracoronary saline 0.9% solution as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Treatment with thrombolytic drugs in the previous 24 hours.
- Known malignancy.
- Thrombocytopenia.
- End-stage liver disease.
- Cardiogenic shock.
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 |
|---|---|---|
| Intracoronary tirofibanAlso: AggrastatPatients will receive intracoronary tirofiban (Aggrastat®) (25 mg/kg). | Drug | Intracoronary tirofiban group |
| Saline 0.9%Patients will receive intracoronary saline 0.9% solution as a control group. | Drug | Control group |
Primary outcome
Blood stream
Time frame: After treatment (Up to 15 minutes)
Blood stream in coronary artery before and after treatment, including Thrombolysis in Myocardial Infarction (TIMI) flow grade in IRAs, coronary blood flow will be calculated with TIMI frame count method.
1 secondary outcome
Incidence of major adverse cardiac events
Time frame: After treatment (Up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for No-Reflow
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
RecruitingPhase 4
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
RecruitingObservational study
A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden
ST Elevation Myocardial Infarction (STEMI), Acute Coronary Syndromes (ACS)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracoronary tirofiban and Saline 0.9% in people with No-Reflow and STEMI, run by Kafrelsheikh 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Hammad, MD (00201015928694, drhammad879@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood stream (time frame: After treatment (Up to 15 minutes)). 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 13 May 2025.