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No Reflow PhenomenonPhase 2NCT07898709

Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI

A Phase 2 study testing Empagliflozin (SGLT2i), dapagliflozin and Standard medical treatment in people with No Reflow Phenomenon and Reperfusion Injuries, Myocardial, run by Al-Azhar University at 4 sites in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Study Background \& Purpose: The no-reflow phenomenon is a significant complication occurring in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). It leads to poor myocardial perfusion despite successful opening of the culprit coronary artery. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Empagliflozin (SGLT2i), dapagliflozin and Standard medical treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesEgypt
Study dates
Jan 2027to Aug 2027
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female patients aged 18-75 years.
  • Confirmed acute myocardial infarction.
  • Will undergo percutaneous coronary intervention (PCI).
  • Ability to receive the study medication before PCI without delaying the clinically indicated procedure.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

Who cannot join

  • Patients meeting any of the following criteria will be excluded:
  • Hemodynamically unstable patients(systolic blood pressure <90 mmHg or mean arterialpressure < 60 mmHg).
  • History of coronary artery bypass graft surgery.
  • Ongoing treatment with SGLT2 inhibitors.
  • Known allergy to SGLT2 inhibitors.
  • Acute kidney injury or estimated glomerular filtration rate <30 mL/min/1.73 m².
Show all 13Show fewer
  • Severe hepatic impairment.
  • Type 1 diabetes mellitus or history of diabetic ketoacidosis.
  • Active infection or recurrent urinary/genital infections.
  • Severe dehydration or clinical condition predisposing to volume depletion.
  • For women of childbearing age:
  • Current or planned pregnancy or lactation.
  • Current Participation in another clinical trial or having participated in the week prior to recruitment

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mennatullah Wael Abd El Samie, Bachelor's Degree in Pharmacy contact

+201211679217

Mennawael07@gmail.com

Egypt4 sites
  • Al Hussein University Hospital

    Cairo

    Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy, +201211679217, Mennawael07@gmail.com

    Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy

  • Al-Zahraa University Hospital

    Cairo

    Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy, +201211679217, Mennawael07@gmail.com

    Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy

  • Islamic Cardiac Surgery Center , Al-Azhar University

    Cairo

    Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy, +201211679217, Mennawael07@gmail.com

    Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy

  • Sayed Galal University Hospital

    Cairo

    Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy, +201211679217, Mennawael07@gmail.com

    Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy

Other trials in Egypt

About this study

Official title: Evaluation of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Administration as Adjunctive Therapies for the Reduction of the No-reflow Phenomenon in Patients With Myocardial Infarction Undergoing Percutaneous Coronary Intervention (PCI): A Randomized Controlled Trial

Study Background \& Purpose:

The no-reflow phenomenon is a significant complication occurring in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). It leads to poor myocardial perfusion despite successful opening of the culprit coronary artery. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardioprotective mechanisms beyond glucose control.

Read more

Objective:

This randomized controlled trial aims to evaluate the effectiveness and safety of administering SGLT2 inhibitors as adjunctive therapy in reducing the incidence of the no-reflow phenomenon in patients with myocardial infarction undergoing PCI.

Study Plan:

Eligible patients presenting with myocardial infarction scheduled for PCI will be randomized into three groups: one group receiving standard pharmacological care plus Empagliflozin therapy, second group receiving standard pharmacological care plus dapagliflozin therapy, and the control group receiving standard pharmacological care alone. Patients will be monitored during and after the procedure to evaluate coronary blood flow and incidence of no reflow phenomenon.

Being tested
Empagliflozin (SGLT2i), dapagliflozin, Standard medical treatment
Keywords
No Reflow Phenomenon, Myocardial Infarction, Sodium Glucose Co-Transporter 2 Inhibitors, Empagliflozin, Dapagliflozin
Medical subject headings
No-Reflow Phenomenon, Myocardial Reperfusion Injury, Myocardial Infarction, ST Elevation Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin (SGLT2i)Drug

    Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines in addition to empagliflozin orally as a single oral dose before PCI, followed by empagliflozin orally once daily for three days.

  • dapagliflozinDrug

    Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines in addition to dapagliflozin orally as a single oral dose before PCI, followed by dapagliflozin orally once daily for three days.

  • Standard medical treatmentDrug

    Patients will receive standard guideline-directed treatment in accordance with current clinical guidelines and undergo percutaneous coronary intervention without receiving any study medication.

Study groups in NCT07898709
Study groupRoleWhat they receive
Standard Care (Control)Active comparatorPatients with myocardial infarction undergoing PCI will receive standard of care pharmacological Treatment alone.
Receives: Drug: Standard medical treatment
Standard Care (Control) + EmpagliflozinExperimentalPatients with myocardial infarction undergoing PCI will receive standard of care pharmacological Treatment in addition to empagliflozin orally as a single oral dose before PCI, followed by empagliflozin orally once daily for three days.
Receives: Drug: Empagliflozin (SGLT2i); Drug: Standard medical treatment
Standard Care (Control) + DapagliflozinExperimentalPatients with myocardial infarction undergoing PCI will receive standard of care pharmacological Treatment in addition to Dapagliflozin orally as a single oral dose before PCI, followed by empagliflozin orally once daily for three days.
Receives: Drug: dapagliflozin; Drug: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of angiographic no-reflow/impaired myocardial reperfusion

    Angiographic no-reflow/impaired myocardial reperfusion, defined as TIMI flow grade.

    Measured: Periprocedural(At completion of PCI)

Secondary outcomes (1)
  1. Incidence Contrast induced-Acute Kidney injury(CI-AKI)

    Contrast induced-Acute Kidney injury(CI-AKI) measured by serum creatinine

    Measured: up to 72 hours Post PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07898709
Sponsor's protocol ID
SGLT2-PCI-2026
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng XT, Xie HY, Wang XH, Zhao Y, Yang JY, Liu YX, Yuan XL, Tang HF, Jiang ZS, Hu HJ. SGLT2 inhibitors: mechanisms, physiology and pharmacology, and clinical applications. Mol Biomed. 2026 Sep 30;7(1):191. doi: 10.1186/s43556-026-00604-3.

    PubMed 42814168
  • Thomas KS, Puthooran DM, Edpuganti S, Reddem AL, Jose A, Akula SSM. Reperfusion injury in STEMI: a double-edged sword. Egypt Heart J. 2025 Sep 5;77(1):83. doi: 10.1186/s43044-025-00683-7.

    PubMed 40911117
  • Talha KM, Anker SD, Butler J. SGLT-2 Inhibitors in Heart Failure: A Review of Current Evidence. Int J Heart Fail. 2023 Mar 13;5(2):82-90. doi: 10.36628/ijhf.2022.0030. eCollection 2023 Apr.

    PubMed 37180562
  • Sun L, Guan R, Gao M, Gu Z, Zhang M. Myocardial ischemia-reperfusion injury after acute myocardial infarction: spatiotemporal mechanisms and endotype-matched multi-target modulation by compounds from traditional Chinese medicine. Front Cardiovasc Med. 2026 Apr 15;13:1797330. doi: 10.3389/fcvm.2026.1797330. eCollection 2026.

    PubMed 42064857
  • Stielow M, Fijalkowski L, Alaburda A, Grzesk G, Grzesk E, Nowaczyk J, Nowaczyk A. SGLT2 Inhibitors: From Molecular Mechanisms to Clinical Outcomes in Cardiology and Diabetology. Molecules. 2025 Jul 25;30(15):3112. doi: 10.3390/molecules30153112.

    PubMed 40807290
  • Nikolaou PE, Konijnenberg LSF, Kostopoulos IV, Miliotis M, Mylonas N, Georgoulis A, Pavlidis G, Kuster CTA, van Reijmersdal VPA, Luiken TTJ, Agapaki A, Roverts R, Orologas N, Grigoriadis D, Pallot G, Boucher P, Kostomitsopoulos N, Pieper MP, Germain S, Loukas Y, Dotsikas Y, Ikonomidis I, Hatzigeorgiou AG, Tsitsilonis O, Zuurbier CJ, Nijveldt R, van Royen N, Andreadou I. Empagliflozin in Acute Myocardial Infarction Reduces No-Reflow and Preserves Cardiac Function by Preventing Endothelial Damage. JACC Basic Transl Sci. 2024 Aug 30;10(1):43-61. doi: 10.1016/j.jacbts.2024.08.003. eCollection 2025 Jan.

    PubMed 39958474
  • Li K, Zhang B, Zheng B, Zhang Y, Huo Y. Reperfusion Strategy of ST-Elevation Myocardial Infarction: A Meta-Analysis of Primary Percutaneous Coronary Intervention and Pharmaco-Invasive Therapy. Front Cardiovasc Med. 2022 Mar 17;9:813325. doi: 10.3389/fcvm.2022.813325. eCollection 2022.

    PubMed 35369319
  • James S, Erlinge D, Storey RF, McGuire DK, de Belder M, Eriksson N, Andersen K, Austin D, Arefalk G, Carrick D, Hofmann R, Hoole SP, Jones DA, Lee K, Tygesen H, Johansson PA, Langkilde AM, Ridderstrale W, Parvaresh Rizi E, Deanfield J, Oldgren J. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024 Feb;3(2):EVIDoa2300286. doi: 10.1056/EVIDoa2300286. Epub 2023 Nov 11.

    PubMed 38320489
  • Herrera CJ, Levenson BJ, Natcheva A, Lucca AC, Olsson K, Miki K, Fong A, Jollis JG, McCormick A, Wilson BH. Improving STEMI Management Internationally: Initial Report of the American College of Cardiology-Global Heart Attack Treatment Initiative. JACC Adv. 2024 Dec 10;4(1):101438. doi: 10.1016/j.jacadv.2024.101438. eCollection 2025 Jan.

    PubMed 39737139
  • Gibson CM, Ajmi I, von Koenig CL, Turco MA, Stone GW. Pressure-Controlled Intermittent Coronary Sinus Occlusion: A Novel Approach to Improve Microvascular Flow and Reduce Infarct Size in STEMI. Cardiovasc Revasc Med. 2022 Dec;45:9-14. doi: 10.1016/j.carrev.2022.07.007. Epub 2022 Jul 28.

    PubMed 35918254
  • Elendu C, Amaechi DC, Elendu TC, Omeludike EK, Alakwe-Ojimba CE, Obidigbo B, Akpovona OL, Oros Sucari YP, Saggi SK, Dang K, Chinedu CP. Comprehensive review of ST-segment elevation myocardial infarction: Understanding pathophysiology, diagnostic strategies, and current treatment approaches. Medicine (Baltimore). 2023 Oct 27;102(43):e35687. doi: 10.1097/MD.0000000000035687.

    PubMed 37904413
  • Butler J, Jones WS, Udell JA, Anker SD, Petrie MC, Harrington J, Mattheus M, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, Figtree G, Ge J, Goodman SG, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Hernandez AF. Empagliflozin after Acute Myocardial Infarction. N Engl J Med. 2024 Apr 25;390(16):1455-1466. doi: 10.1056/NEJMoa2314051. Epub 2024 Apr 6.

    PubMed 38587237
  • Bouleti C, Mewton N, Germain S. The no-reflow phenomenon: State of the art. Arch Cardiovasc Dis. 2015 Dec;108(12):661-74. doi: 10.1016/j.acvd.2015.09.006. Epub 2015 Nov 23.

    PubMed 26616729
  • Bashir H, Berkha FNU, Malik J, Perveen A. Clinical and Angiographic Predictors of No-Reflow and Its Impact on Outcomes in ST-Elevation Myocardial Infarction: A Retrospective Study. Clin Cardiol. 2026 Jun;49(6):e70374. doi: 10.1002/clc.70374.

    PubMed 42296130
  • Annibali G, Scrocca I, Aranzulla TC, Meliga E, Maiellaro F, Musumeci G. "No-Reflow" Phenomenon: A Contemporary Review. J Clin Med. 2022 Apr 16;11(8):2233. doi: 10.3390/jcm11082233.

    PubMed 35456326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin (SGLT2i), dapagliflozin and Standard medical treatment in people with No Reflow Phenomenon and Reperfusion Injuries, Myocardial, run by Al-Azhar University at 4 sites 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 phase mean?

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?

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 Mennatullah Wael Abd El Samie, Bachelor's Degree in Pharmacy (+201211679217, Mennawael07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of angiographic no-reflow/impaired myocardial reperfusion (time frame: Periprocedural(At completion of PCI)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07898709, which also lists 17 linked publications.

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 27 Oct 2026.

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