Polypill For Prevention of Cardiovascular Disease

NCT00567307 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00004134SLCTR/ 2007/012
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of the Estimated 10-year Total Cardiovascular Risk Score

  Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk

  Six months

Study Arms (2)

The Red Heart Pill 2b (Polypill) (A)

EXPERIMENTAL

The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide

Drug: Red Heart Pill 2b (Polypill)

Standard Practice Group (B)

ACTIVE COMPARATOR

Standard Practice

Other: Standard Practice

Interventions

Red Heart Pill 2b (Polypill) DRUG

Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)

Also known as: Polypill

The Red Heart Pill 2b (Polypill) (A)

Standard Practice OTHER

Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Also known as: Usual care

Standard Practice Group (B)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated 10-year total CVD risk score \> 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
• No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
• Informed consent given

You may not qualify if:

• Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
• Patients with secondary hypertension
• Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
• Known renal failure or impairment
• Atrial fibrillation
• ALT \> 1.5 times the upper limit of normal
• History of liver cirrhosis or hepatitis
• History of recent gastrointestinal bleeding (within the last year)
• Women in child bearing period
• History of life-limiting diseases or events
• Unwillingness to sign informed consent.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• World Health Organization: collaborator
• National Hospital of Sri Lanka: collaborator

Study Sites (3)

The National Hospital of Sri Lanka

Colombo, Colombo10, Sri Lanka

Location

Teaching (General) Hospital Kandy

Kandy, Sri Lanka

Location

Teaching (General) Hospital Kegalle

Kegalle, Sri Lanka

Location

Related Publications (1)

• Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3.

  PMID: 21205325 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Elsayed Z Soliman, Director of the Epidemiological Cardiology Research Center
• Organization: Wake Forest School of Medicine, Winston Salem, NC

esoliman@wakehealth.edu

336-716-8632

Study Officials

• Elsayed Z Soliman, MD, MSc, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Shanthi Mendis, MD, FRCP

  World Heath Organization

  STUDY DIRECTOR

• Curt D Furberg, MD, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 4, 2007
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 10, 2018
• Results First Posted: December 16, 2016

Record last verified: 2018-08

Locations

SR (3)