Last reviewed · How we verify
NCT03757156
Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease
NA trial testing Withdrawal of aspirin in Healthy Participants With Moderate and High Cardiovascular Risk in 4,118 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 4,118 |
| Start date | 1 March 2019 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Withdrawal of aspirin
Conditions studied
- Healthy Participants With Moderate and High Cardiovascular Risk — all drugs for Healthy Participants With Moderate and High Cardiovascular Risk →
Sponsor
Yonsei University
Who can join
Adults 19 to 80, any sex, with Healthy Participants With Moderate and High Cardiovascular Risk. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Major adverse cardiovascular events(MACE)
Time frame: 5 years
Major adverse cardiovascular events is composite endpoint. It includes cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft), nonfatal ischemic stroke, and transient ischemic attack.
Sponsor's own description
While the efficacy of aspirin for the secondary prevention of cardiovascular disease is evident, the effect of aspirin for primary prevention is unclear. The use of aspirin reduces cardiovascular mortality and myocardial infarction but increases side effects such as bleeding. Therefore, the use of aspirin for primary prevention in people without cardiovascular disease should be determined by individual risk and clinical benefit. The European guidelines have been changed to not recommend aspirin use in people without cardiovascular disease, but there are still people taking aspirin for primary prevention. The purpose of this study is to investigate the effect of aspirin withdrawal on cardiovascular events in patients without cardiovascular disease. This is a single center, prospective, randomized clinical study evaluating the safety and efficacy of withdrawal of aspirin among patients with moderate or high cardiovascular risk.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03757156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03757156 (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 Yonsei University
- Last refreshed: 7 February 2019
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/NCT03757156.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing