A clinical trial to evaluate the effects of lipid modification with rosuvastatin and of blood pressure lowering with candesartan/hydrocholorothiazide(HCT) and their combination in a wide range of middle aged people who are at average risk of vascular events

Phase 3

Completed

• Registration Number: CTRI/2007/091/000016
• Lead Sponsor: Population Health Research Institute

Brief Summary

Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial we will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk. The trial will enroll 10,000 women 65 years or older and men 55 years or older without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. From India the plan is to recruit at least 3000 subjects. Eligible and consenting individuals will be randomized to receive either the real study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The rates of heart attacks, strokes, deaths and other cardiovascular complications will be compared between subjects receiving the real drugs and those on placebo. The study will include people from at least ten countries, will be monitored an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at McMaster University. The study is expected to demonstrate that combined lipid lowering and blood pressure lowering will substantially lower the risk for cardiovascular diseases and may substantially change our approach to cardiovascular prevention. The trial received HMSC clearance and  DCG(I) approval. The recruitment was completed in Nov 2010. The active follow-up phase of the study (for up to eight years) had completed on 31st Oct 2015. The study is in the passive follow-up phase wherein subjects will be followed up for at least ten years. It is an yearly follow-up either through telephone or clinic visit. Please note that during the passive follow-up phase, the subjects will not be on study drugs. 13 out of 23 sites have agreed to participate in passive follow-up as on May 2016.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Study Completion: 2019-01-31
• Last Update Posted: 2024-06-19

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10000

Inclusion Criteria

Women aged > 65 years and men > 55 years One additional CV risk factor including: Waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women; History of current or recent smoking (regular tobacco use within 5 years) Low HDL cholesterol Dysglycemia Renal dysfunction Family history of premature CHD in first degree relatives.

Exclusion Criteria

Documented clinically manifest atherothrombotic CVD Clear indication or contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy Symptomatic hypotension Chronic liver disease Inflammatory muscle disease Severe renal impairment Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine Concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic Other serious medical illness likely to interfere with study participation or with the ability to complete the trial Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures Concurrent use of an experimental pharmacological agent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of lipid modification (LDL cholesterol lowering and HDL cholesterol raising) with rosuvastatin 10 mg daily on major CV events. To evaluate the effects of blood pressure lowering with combined candesartan 16 mg/HCT 12.5 mg daily on major CV events. To evaluate the impact of combined lipid modification with rosuvastatin 10 mg/day and blood pressure lowering with candesartan 16 mg/HCT 12.5 mg daily on major CV events	5 years

Secondary Outcome Measures

Name	Time	Method
Total mortality CV mortality Coronary heart disease events Cerebrovascular disease events Heart failure Revascularization procedures Angina pectoris Progression of renal disease New diagnosis of diabetes	5 years

Trial Locations

Locations (23)

Aditya Nursing Home; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Baby Memorial Hospital Calicut; 🇮🇳 Kozhikode, KERALA, India

Belgaum Diabetes Centre; 🇮🇳 Belgaum, KARNATAKA, India

Bethesda Hospital; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Cresent Hospital and Heart Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Fortis Escorts hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Health Harmony hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Life Care Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Madras Diabetic Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

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Aditya Nursing Home

🇮🇳Kurnool, ANDHRA PRADESH, India

Dr B Srinivasulu

Principal investigator

adityanursinghome@yahoo.com