NCT04111419

Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation

Name: Clinical Trial NCT04111419
Creator: Shanghai Jiao Tong University School of Medicine
Keywords: Atrial Fibrillation,Hypertension, Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Phase 4, drug, clinical trial, China

Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION)

Shanghai Jiao Tong University School of Medicine·Phase 4·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Atrial Fibrillation,Hypertension
Drug/Device/Intervention: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Shanghai Jiao Tong University School of Medicine
Location: Shanghai, China

Timeline & enrollment

Phase: Phase 4
Start date: Jul 01, 2020
End date: Dec 31, 2024
Enrollment: 1200 participants

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

Chronic atrial fibrillationPersistent atrial fibrillationParoxysmal atrial fibrillationAtrial fibrillation and flutterAtrial fibrillation and atrial flutter, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04111419
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.