Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease

Condition(s) targeted: Cardiovascular Disease; Hypertension; Hyperlipidemia; Heart Disease

Intervention: Heart polypill (Atorvastatin, Asprin, Enalapril, Hydrochlorothiazide) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Reza Malekzadeh, M.D., Principal Investigator, Affiliation: Tehran University of Medical Sciences
Fatemeh Malekzadeh, M.D., Study Director, Affiliation: Tehran University of Medical Sciences
Akram Pourshams, M.D., Study Chair, Affiliation: Tehran University of Medical Sciences
Mansoor Rastegarpanah, Ph.D., Principal Investigator, Affiliation: Tehran University of Medical Sciences

Overall contact:
Mansoor Rastegarpanah, Ph.D., Phone: +98912-125-5960, Email: rastegar@sina.tums.ac.ir

The cardio vascular diseases are the main cause of death all around the world. About 45% of the death in Iran relates to this disease. We therefore aimed to establish whether use of evidence-based combination drug regimens such as polypill is efficacious and safe to use in primary prevention. There are some studies, which established that four effective medicines in one tablet had a better compliance of the patients and had fewer side effects.

Methods:

The first double blind clinical research was designed to study morbidity and mortality in 2 groups of patients in a randomized manner 500 healthy volunteers and will be followed up for 1 year. One group will take a tablet of polypill, which contain three types of medicine effective in cardio vascular disease. This tablet contains a drug of preventing platelet aggregation aspirin (81mg), two drugs of reducing blood pressure containing ACE inhibitor enalapril (2. 5mg) and one diuretic drug such as hydrochlorothiazide (12. 5mg) and one reducing hyperlipidemia from the group of Statins Atorvastatin (20mg) and in the other group will take placebo.

Official title: Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction of the mortality/morbidity due to cardiovascular disease, adverse drug reaction and adherence by heart polypill

Secondary outcome: Patients' and physicians acceptability of heart polypill

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Men's with the age between 50 to 80 and women with the age between 60 to 80

2. Participants have not been administered for any anti-hypertensive drug recently.

3. Participants have not been administered for any diuretic drug.

4. There are no contraindications for administration of thiazide diuretics (allergic reaction or gout)

5. Participants should have systolic blood pressure between 100 to 140 mmHg

6. Participants should have diastolic blood pressure between 60 to 90 mmHg

7. Decline in systolic blood pressure should not be over 10 mmHg

Excluding criteria:

1. Administration of one of the component of polypill.

2. Use of any anti-hypertensive drugs

3. Use of aspirin

4. Use of statin

5. Existence of contraindication for any component of poly pill.

6. Existence of history for allergic reaction after administration of aspirin.

7. Existence of active peptic ulcers for recent 2 years

8. Any liver disease

9. Systolic blood pressure<100mmHg and diastolic pressure <70 mmHg

10. Existence of symptomatic orthostatic hypotension

11. Existence of hyperuricemia or gout

Mansoor Rastegarpanah, Ph.D., Phone: +98912-125-5960, Email: rastegar@sina.tums.ac.ir

Kalaleh Heart Study Center, Kalaleh, Golestan, Iran, Islamic Republic of; Recruiting
Fatemeh Malekzadeh, M.D., Phone: +9821, Email: Fmalek@ams.ac.ir

Starting date: November 2006
Ending date: June 2008
Last updated: April 22, 2008