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NCT05579418
The Safety and Long-Term Clinical Benefit of PCSK9i in STEMI Patients
Phase 4 trial testing Evolocumab in STEMI in 350 participants. Status unknown.
30 October 2024
Quick facts
| Lead sponsor | Hamad Medical Corporation |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 1 November 2022 |
| Primary completion | 30 October 2024 |
| Estimated completion | 30 October 2024 |
Drugs / interventions tested
- Evolocumab (EVOLOCUMAB) — full drug profile →
Conditions studied
- STEMI — all drugs for STEMI →
- Dyslipidemias — all drugs for Dyslipidemias →
Sponsor
Hamad Medical Corporation — full company profile →
Who can join
Adults 18 to 70, any sex, with STEMI or Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with acute coronary syndromes (ACS) have an increased risk of recurrent ischemic events, particularly during the first year following the index event, which is mainly due to unattended risk factors and/ or poor compliance with medications. Lowering low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular morbidity and mortality in patients with atherosclerotic cardiovascular disease (ASCVD), with a magnitude of clinical benefit that is proportional to the reduction in LDL-C levels. Proprotein convertase subtilisin/ kexin type 9 (PCSK9) antibodies have emerged as a new class of drugs that rapidly and effectively lower LDL-C levels up to 77 % of the original value in combination with statins. The primary objective of this study is to confirm the safety and the long-term clinical benefit associated with the use of PCSK9i when combined with statin in patients with ACS-STEMI. The study is an investigator-initiated, prospective, randomized, open label study that will be the first study looking for the safety and the clinical benefit and outcome associated with the use of PCSK9i in ACS-STEMI patients specifically. Internationally, this will be the first trial studying the effect of PCSK9i on patients with acute myocardial infarction (STEMI) in terms of reduction in cholesterol level and reduction in cardiac events rate (re-infarction and cardiac death) after myocardial infarction. This trial will have a significant impact in the management of patients with STEMI, locally and internationally and it will be conducted purely in Qatar. This trial will help to improve the clinical outcome of patients in Qatar in terms of reduction of myocardial reinfarction rate and mortality.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05579418
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05974345 — In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established C · completed
Other recruiting trials for STEMI
Currently open trials in the same condition.
- NCT06966674 — No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track · NA · recruiting
- NCT06678074 — Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI · Phase 1, PHASE2 · active not recruiting
- NCT07055152 — Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients · recruiting
- NCT06528821 — AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS · active not recruiting
- NCT07026708 — TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevat · recruiting
Other Hamad Medical Corporation trials
Trials by the same sponsor.
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- NCT07270939 — Optimizing Enteral Nutrition Regimen for Critically Ill Patients · NA · not yet recruiting
- NCT07307508 — Efficacy of Scalp Block in Managing Post Subarachnoid Hemorrhage Headache in Critically Ill Patients. A Single Centre Ra · NA · recruiting
- NCT06622577 — The Effect of Dietary Management and Cysteine Supplementation on Growth Parameters and Biochemical Control for Pediatric · NA · not yet recruiting
- NCT06887855 — Enhancing Post-Stroke Dysphagia Rehabilitation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05579418 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hamad Medical Corporation
- Last refreshed: 13 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05579418.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing