Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 582
- Locations
- 1
- Primary Endpoint
- major adverse cardiovascular events (MACE)
Study Overview
Brief Summary
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded
Detailed Description
In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Group A, group B
Eligibility Criteria
- Ages
- 52 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients who have undergone PCI due to chronic stable angina
Exclusion Criteria
- •Patients with acute coronary syndrome
- •Primary LDL>190 mg/DL
- •Patients who developed statin-induced myopathy or rhabdomyolysis
- •Persistent increase in hepatic enzyme levels or hepatic failure
- •Pregnancy and breast feeding
- •Statin hypersensitivity
- •Patients with history of multiple atherosclerotic events
- •Patients who received high intensity statin before the study enrollment.
Arms & Interventions
moderate dose statin
Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day
Intervention: moderate statin dose (Drug)
high dose statin
patients 1 month post PCI, allocated to 40 mg rosuvastatin
Intervention: high dose statin (Drug)
Outcomes
Primary Outcomes
major adverse cardiovascular events (MACE)
Time Frame: 1 year
major adverse cardiovascular events
serum level of HS-CRP
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Javad Kojuri
Professor
Shiraz University of Medical Sciences