Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation - Trial NCT04111419
Access comprehensive clinical trial information for NCT04111419 through Pure Global AI's free database. This Phase 4 trial is sponsored by Shanghai Jiao Tong University School of Medicine and is currently Recruiting. The study focuses on Atrial Fibrillation,Hypertension. Target enrollment is 1200 participants.
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Study Focus
Sponsor & Location
Shanghai Jiao Tong University School of Medicine
Timeline & Enrollment
Phase 4
Jul 01, 2020
Dec 31, 2024
Primary Outcome
Combined cardiovascular end-point events
Summary
1. Study name: Intensive management of blood pressure and cholesterol in elderly Chinese
 with hypertension and atrial fibrillation (IMPRESSION)
 
 2. Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg
 tablet); allisartan (240mg/tablet).
 
 3. Rationale: controlling blood pressure and cholesterol are both effective means to reduce
 cardiovascular risks, however, it is still unknown whether high cardiovascular risk
 patients with atrial fibrillation would benefit from intensive management of blood
 pressure and cholesterol.
 
 4. Objective: To evaluate the efficacy and safety of intensive management of blood pressure
 and cholesterol.
 
 5. Study design: This study is a multi-center, randomized and controlled clinical trial
 with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet);
 amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg
 tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan
 (240mg/tablet).
 
 6. Study population: Men and Women aged over 65 years (n=1200) meeting the
 inclusion/exclusion criteria.
 
 7. Randomization and treatment: After stratification by centers, eligible patients will be
 randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a
 day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin
 (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg
 tablet)+allisartan (240mg/tablet) once a day.
 
 8. Follow up: 3 years.
 
 9. Sample size: a total of 1200 patients should be enrolled in the combination.
 
 10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in
 September 2019, recruitment will start. Patients enrollment will be performed between
 November 2019 to November 2020. All patients should be followed up before December 2023.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04111419
Non-Device Trial