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Not yet recruitingNCT07898709Updated Oct 27, 2026

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

A Phase 2 interventional study of Empagliflozin (SGLT2i) and dapagliflozin in No Reflow Phenomenon, Reperfusion Injuries, Myocardial and Myocardial Infarction, sponsored by Al-Azhar University. Not yet recruiting at 4 sites in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Al-Azhar University · Phase 2, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardioprotective mechanisms beyond glucose control.

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.

02

Conditions studied

  • No Reflow Phenomenon
  • Reperfusion Injuries, Myocardial
  • Myocardial Infarction
  • STEMI - ST Elevation Myocardial Infarction
  • Coronary Artery Disease (CAD)
  • PCI
  • Sodium Glucose Co-Transporter 2 Inhibitors
  • Empagliflozin
  • Dapagliflozin

Keywords

  • No Reflow Phenomenon
  • Myocardial Infarction
  • Sodium Glucose Co-Transporter 2 Inhibitors
  • Empagliflozin
  • Dapagliflozin
03

In context

No-Reflow Phenomenon

25 studies on the registry are indexed under No-Reflow Phenomenon; 9 are open to participants now.

This study's planned enrollment of 100 is below the median of 201 across 17 interventional studies indexed under No-Reflow Phenomenon.

Browse No-Reflow Phenomenon studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 527 studies on the registry; 171 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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.
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Standard Care (Control)

    Patients with myocardial infarction undergoing PCI will receive standard of care pharmacological Treatment alone.

    Drug: Standard medical treatment

  • Experimental
    Standard Care (Control) + Empagliflozin

    Patients 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.

    Drug: Empagliflozin (SGLT2i) · Drug: Standard medical treatment

  • Experimental
    Standard Care (Control) + Dapagliflozin

    Patients 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.

    Drug: dapagliflozin · Drug: Standard medical treatment

Interventions

  • 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.

  • 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.

  • DrugStandard medical treatment

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Periprocedural(At completion of PCI)

Secondary outcomes

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

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

    Time frame: up to 72 hours Post PCI

07

Study locations

4 sites
  • Al Hussein University Hospital
    Cairo, Egypt
    • Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy · ContactMennawael07@gmail.com · +201211679217
    • Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy · Principal investigator
    • Zeinab AlKasaby Mahmoud Zalat, Prof. Dr., PhD · Sub investigator
    • Mostafa Attia Al-Sawasany, Prof. Dr., MD · Sub investigator
    • Dina Mohamed Ibrahim Ibrahim, Lecturer, PhD · Sub investigator
  • Al-Zahraa University Hospital
    Cairo, Egypt
    • Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy · ContactMennawael07@gmail.com · +201211679217
    • Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy · Principal investigator
    • Zeinab AlKasaby Mahmoud Zalat, Prof. Dr., PhD · Sub investigator
    • Mostafa Attia Al-Sawasany, Prof. Dr., MD · Sub investigator
    • Dina Mohamed Ibrahim Ibrahim, Lecturer, PhD · Sub investigator
  • Islamic Cardiac Surgery Center , Al-Azhar University
    Cairo, Egypt
    • Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy · ContactMennawael07@gmail.com · +201211679217
    • Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy · Principal investigator
    • Zeinab AlKasaby Mahmoud Zalat, Prof. Dr., PhD · Sub investigator
    • Mostafa Attia Al-Sawasany, Prof. Dr., MD · Sub investigator
    • Dina Mohamed Ibrahim Ibrahim, Lecturer, PhD · Sub investigator
  • Sayed Galal University Hospital
    Cairo, Egypt
    • Mennatullah Wael Abd El Samie, Bachelor's in Pharmacy · ContactMennawael07@gmail.com · +201211679217
    • Mennatullah Wael Abd El Samie Mostafa, Bachelor's in Pharmacy · Principal investigator
    • Zeinab AlKasaby Mahmoud Zalat, Prof. Dr., PhD · Sub investigator
    • Mostafa Attia Al-Sawasany, Prof. Dr., MD · Sub investigator
    • Dina Mohamed Ibrahim Ibrahim, Lecturer, PhD · Sub investigator
08

References and documents

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 ↗
  • Alsadder L, Hamadah A. Cardiac Ischaemia-Reperfusion Injury: Pathophysiology, Therapeutic Targets and Future Interventions. Biomedicines. 2025 Aug 27;13(9):2084. doi: 10.3390/biomedicines13092084. PubMed 41007647 ↗
  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available. PubMed 37622654 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jun 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 27, 2026
StartEst.
Jan 2027
Primary completionEst.
Jun 2027
CompletionEst.
Aug 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898709
Responsible party
Mennatullah Wael Abd El Samie (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Oct 27, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Empagliflozin · Dapagliflozin

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