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

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record status
This record was last updated August 13, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 31, 2026 to Sep 30, 2026v8
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v6
  4. Primary and study completion dates: Nov 1, 2023 to Dec 31, 2024v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 1, 2019 to Jul 1, 2020v3
  2. Eligibility criteria shortened, about 53 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04111419
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Atrial Fibrillation, Hypertension
Related terms Atrial Fibrillation, Hypertension
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov