Last reviewed · How we verify
NCT03599284
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
Phase 2 trial testing Vicagrel 5mg in Coronary Artery Disease in 279 participants. Completed in 28 July 2019.
11 June 2019
Quick facts
| Lead sponsor | Jiangsu vcare pharmaceutical technology co., LTD |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 279 |
| Start date | 30 August 2018 |
| Primary completion | 11 June 2019 |
| Estimated completion | 28 July 2019 |
| Sites | 27 locations across China |
Drugs / interventions tested
- Vicagrel 5mg — full drug profile →
- Vicagrel 6mg — full drug profile →
- Vicagrel 7.5mg — full drug profile →
- Clopidogrel 75mg — full drug profile →
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
- Platelet Aggregation Inhibitors — all drugs for Platelet Aggregation Inhibitors →
Sponsor
Jiangsu vcare pharmaceutical technology co., LTD — full company profile →
Who can join
Adults 18 to 75, any sex, with Coronary Artery Disease or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention (PCI) will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03599284
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Jiangsu vcare pharmaceutical technology co., LTD trials
Trials by the same sponsor.
- NCT07533851 — A Food Effect Study of VC005 Tablets in Healthy Adult Subjects. · Phase 1 · not yet recruiting
- NCT07172360 — Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis. · Phase 3 · recruiting
- NCT07329101 — Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VC005 in Adolescent Subjects With Mild to Modera · Phase 1 · completed
- NCT07172347 — Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo · Phase 2 · recruiting
- NCT07067775 — Pharmacokinetic/Pharmacodynamic Study of Vicagrel Capsules and Clopidogrel Tablets in Healthy CYP2C19 Normal Metabolizer · Phase 1 · completed
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 NCT03599284 (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 Jiangsu vcare pharmaceutical technology co., LTD
- Last refreshed: 23 September 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/NCT03599284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing