NCT03007524

Early Vascular Healing in Acute Coronary Syndrome Patients With Different Doses of Rosuvastatin

A Randomized Comparison of Low-dose Versus High-dose Rosuvastatin on Optical Coherence Tomography Based Early Vascular Healing for Patients With Acute Coronary Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. Through the study, the investigators aim to evaluate the effects of high dose rosuvastatin calcium on "target vessel" endothelialization and "non-target vessel" plaque stability. Moreover, the investigators may provide mechanically evidence of clinical application of high dose rosuvastatin in patients with acute coronary syndrome.

Detailed description

This is a prospective, multicenter, randomized controlled clinical trial comparing different doses of rosuvastatin in patients with acute coronary syndrome post drug-eluting stents implantation. In total, the investigators plan to recruit 80 patients with acute coronary syndrome (but no acute ST-segment elevation myocardial infarction) participating in the study. After signing informed consent form, the patients will be randomly assigned into high dose rosuvastatin and low dose rosuvastatin groups (40 cases in each group) by a computer generated random sequence table on a ratio of 1:1. Patients in the high-dose group will be prescribed rosuvastatin calcium of 20mg/d at least 6 months post index procedure, while patients in low dose group will have rosuvastatin calcium of 10mg/d, also at least 6 months. Additionally, all patients will receive dual antiplatelet therapy (oral aspirin 100mg qd, clopidogrel 75mg qd or ticagrelor 90 mg bid). Clinical follow up (telephone or out-patient follow-up) will be scheduled at 30 days, 6 months, 1 year, 2 years and 3 years. Optical coherence tomography examinations will be performed at 6 months. Neointimal hyperplasia, stent strut coverage and thin cap fibroatheroma are primary observational parameters. Multi-slices CT are optional pre-/post-procedure and at 3 years follow-up. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee. All imaging modalities data will be collected and analysed by an independent imaging core laboratory.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	High dose Rosuvastatin	20mg/d qN, at least 6 months
DRUG	Low dose Rosuvastatin	10mg/d qN, at least 6 months

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2017-01-02
• Last updated: 2017-02-23

Locations

1 site across 1 country: China