Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04111419 |
| Other study ID # |
IMPRESSION |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Shanghai Jiao Tong University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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, especially in hypertensive patients with atrial fibrillation.
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 or women aged over 65 years (n=1200) will be screened for atrial
fibrillation. Atrial fibrillation patients who never took antihypertensive drugs or stop
antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179
mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at
least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood
pressure of 90-109 mmHg will be recruited. Before randomization, two visits should be
performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic
blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic.
Regardless of whether the office blood pressure meets the enrollment conditions, a
one-week home blood pressure measurement should be performed before randomization.
Patient should sign the written consent form before screening and be able to go to the
clinic by him/herself. Exclusion criteria included: suspected or confirmed secondary
hypertension; history of coronary heart disease, myocardial infarction, heart failure,
stroke or dementia; taking other drugs that might affect blood pressure; liver
dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum
potassium >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²;
elderly care patients; or patients who are participating in other clinical trials.
7. Randomization and treatment: After stratification by centers, eligible patients will be
randomly divided into four groups, taking amlodipine (5 mg/tablet)+ once a day or
amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet)
once a day.
8. Follow up: Sitting office blood pressures and electrocardiogram should measured by an
OMRON device. Medical history should be recorded. Clinical examinations including home
blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests
should be performed. Patients should be followed up every three months. Before the
follow-up, patients should perform a one-week home blood pressure monitoring.
9. Sample size and statistical analysis: At least 300 eligible patients should be enrolled
in each group, and a total of 1200 patients should be enrolled in total. Data will be
analyzed by using the SAS software. ANOVA will be used to compare the parameters between
groups and the difference between the four groups with the calculation of 95% confidence
interval. In addition, a covariance analysis will also be used in the analysis of
baseline parameters.
10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in
September 2019, recruitment will start. Patients enrollment will be performed between
October 2019 to October 2020. All patients should be followed up before December 2023.
Database construction and statistical analysis will be conducted at the same time,
appropriate domestic and international conferences will be selected to publish the
research results. The main results will be published in international professional
medical journals.
11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin
Hospital, Shanghai, China.
