NCT00603590

Brief Summary

Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages. In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations. This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment. Methods: This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo. The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure \>160/100 mm Hg, total cholesterol \>240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded. It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 23, 2009

Completed
Last Updated

October 2, 2009

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

January 1, 2008

Results QC Date

April 13, 2009

Last Update Submit

September 22, 2009

Conditions

Cardiovascular DiseaseHypertensionHyperlipidemiaHeart Disease

Keywords

Cardiovascular diseaseprimary preventionPolypillefficacysafetyADRDiabetesAdherenceCompliance

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Systolic blood pressure. Mean of two seated measurements.

    One year

Secondary Outcomes (2)

  • Diastolic Blood Pressure

    One year

  • LDL Cholesterol

    One year

Study Arms (2)

Polypill

EXPERIMENTAL

Fixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg

Drug: Polypill

Control

PLACEBO COMPARATOR

Identical placebo

Drug: Placebo drug

Interventions

PolypillDRUG

Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily

Polypill
Placebo drugDRUG

Inactive tablet Once a day Identical in appearance to intervention drug

Control

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.

You may not qualify if:

  • Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
  • Already taking antihypertensive drugs, aspirin or statins
  • Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
  • Blood pressure \>160/100 mm Hg
  • Total Cholesterol \> 240 mg/dL (or LDL \>190 mg/dL)
  • Probable diabetes: HbA1c \>6.0
  • Contraindication to a component of the Polypill
  • Contraindications to aspirin
  • Previous history of allergy to aspirin
  • History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
  • Contraindications to statins
  • Liver failure Contraindications to further blood pressure lowering
  • Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg
  • Symptomatic postural hypotension
  • Difference between mean seated BP and standing BP greater than 20 mm Hg
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalaleh Heart Study Center

Kalāleh, Golestan Province, Iran

Location

Related Publications (1)

  • Rastegarpanah M, Malekzadeh F, Thomas GN, Mohagheghi A, Cheng KK, Marshall T. A new horizon in primary prevention of cardiovascular disease, can we prevent heart attack by "heart polypill"? Arch Iran Med. 2008 May;11(3):306-13. No abstract available.

    PMID: 18426322BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHyperlipidemiasHeart DiseasesDiabetes MellitusPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

Incomplete follow up Because of differences in systolic blood pressure at baseline, final analysis will take account of baseline differences

Results Point of Contact

Title
Mansoor Rastegarpanah
Organization
Tehran University of Medical Sciences
rastegar@sina.tums.ac.ir
+989121255960

Study Officials

  • Reza Malekzadeh, M.D.

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Fatemeh Malekzadeh, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mansoor Rastegarpanah, Ph.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Kar K Cheng, PhD

    University of Birmingham

    STUDY CHAIR

  • Tom P Marshall, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

  • Akram Pourshams, PhD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 29, 2008

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

October 2, 2009

Results First Posted

June 23, 2009

Record last verified: 2009-09

Locations

IR(1)