NCT07229248 DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial
| NCT ID | NCT07229248 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan |
| Condition | STEMI (ST Elevation MI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 496 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 496 participants in total. It began in 2025-11-05 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: ST Elevation Myocardial Infarction (STEMI) in young adults (\<50 yrs) carries high Percutaneous coronary intervention (PCI) risks. While drug-eluting stents (DES) reduce restenosis versus angioplasty, they increase risks of in-stent restenosis, thrombosis, prolonged dual antiplatelet therapy (DAPT), and endothelial dysfunction. Drug-coated balloons (DCB) provide a "leave nothing behind" strategy, potentially mitigating these issues. Evidence, including a JACC CVI report, suggests DCB outcomes comparable to DES in STEMI. South Asia faces a heavy burden. The national Institute of Cardiovascular diseases (NICVD), Karachi performed 17,761 primary PCIs in 2022, with 45% in patients \<50 yrs. Study Design: This single-center Randomized Controlled Trial (RCT) compares paclitaxel-coated DCB (3.0 µg/mm², 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\<50 yrs) undergoing primary PCI. The primary endpoint is 1-year vessel oriented cardiac events (VOCE)= Cardiovascular /all-cause death, target vessel MI, or Target lesion revascularization (TLR). Secondary endpoints include vessel-oriented CV events, bleeding, TIMI III flow, residual stenosis, abrupt closure, and bailout stenting. An intravascular ultrasound (IVUS) substudy (100 DCB pts) will evaluate remodeling and late lumen loss (LLL) at 6 months. Methods: 496 patients (248/arm) will be randomized 1:1, powered for non-inferiority (margin 4.5%) assuming VOCE 8.5% (DES) vs. 6.25% (DCB), 80% power, and 5% dropout. Inclusion: age 18-50, STEMI. Exclusion: End stage renal disease (ESRD), severe multivessel disease, complex lesions, or high thrombus burden. All will receive ticagrelor 90 mg BID for 1 month. A pilot of 50 pts will first assess safety (abrupt closure, lesion prep). Analysis: Intention-to-treat (ITT) will be primary; modified ITT for secondary endpoints. Statistics include chi-square/Fisher for categorical, t-test/Wilcoxon for continuous, and Kaplan-Meier/Cox for survival. Oversight by data safety monitoring board (DSMB) and Events adjudication Committee (EAC). Significance: This trial leverages NICVD's high PCI volume to test DCB as an alternative to DES in young STEMI patients. By avoiding permanent implants, DCB may reduce long-term complications and DAPT needs. The IVUS substudy and pilot phase strengthen rigor. If non-inferiority is proven, DCB could reshape STEMI management in South Asia and similar high-burden regions.
Eligibility Criteria
Inclusion Criteria: * Either gender * Patient of age between 18 to 50 years * Patients with STEMI ( as first presentation of CAD) undergoing Primary PCI * Total ischemic Time less than 8 hrs. * Low syntax score * Stable (Killip I-II) Exclusion Criteria: * Patients with ESRD * Severe 3 VD; Intermediate of High syntax score * Lesion type\>B
Contact & Investigator
Abdul Hakeem, MD
PRINCIPAL INVESTIGATOR
NICVD
Frequently Asked Questions
Who can join the NCT07229248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying STEMI (ST Elevation MI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07229248 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 496 participants.
Is NCT07229248 currently recruiting?
Yes, NCT07229248 is actively recruiting participants. Contact the research team at ahakeem@gmail.com for enrollment information.
Where is the NCT07229248 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07229248 clinical trial?
NCT07229248 is sponsored by National Institute of Cardiovascular Diseases, Pakistan. The principal investigator is Abdul Hakeem, MD at NICVD. The trial plans to enroll 496 participants.