Last reviewed · How we verify
NCT04116931
OPTImal Management of Antithrombotic Agents: OPTIMA-5
Phase 4 trial testing Switch ticagrelor to clopidogrel in Acute Coronary Syndrome (ACS) in 80 participants. Status unknown.
30 May 2021
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 22 June 2020 |
| Primary completion | 30 May 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Switch ticagrelor to clopidogrel — full drug profile →
Conditions studied
- Acute Coronary Syndrome (ACS) — all drugs for Acute Coronary Syndrome (ACS) →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
18 and older, any sex, with Acute Coronary Syndrome (ACS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04116931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other The First Affiliated Hospital with Nanjing Medical University trials
Trials by the same sponsor.
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
- NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT04116931 (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 The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 25 August 2020
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/NCT04116931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing