Condition category
Circulatory System
Date applied
26/12/2005
Date assigned
06/01/2006
Last edited
20/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Subodh Verma

ORCID ID

Contact details

Div of Cardiac Surgery
St. Michael's Hospital
University of Toronto
30 Bond Street
Toronto
M5B 1W8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

4R Trial

Study hypothesis

ACE inhibition, with Ramipril 10 mg per day, will lower C-reactive protein levels in healthy middle-aged volunteers with elevated C-reactive protein levels

Ethics approval

Yes, approved by Institutional Review Board University of Calgary, Faculty of Medicine February 2003 (2003020012Ram)

Study design

Randomized double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Healthy volunteers with elevated levels of C-Reactive protein

Intervention

Ramipril 10 mg per day versus placebo for 12 weeks

Intervention type

Drug

Phase

Not Specified

Drug names

Ramipril

Primary outcome measures

Change in CRP levels in Ramipril versus placebo arms

Secondary outcome measures

Change in endothelial function assessed by pulse wave tomography (photoacoustic tomography [PAT])

Overall trial start date

01/03/2003

Overall trial end date

30/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

35-80 years of age, male or female, free of cardiovascular disease, and baseline CRP greater than 2 mg/l

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Structural heart disease or vascular disease
2. Systolic blood pressure greater than 160 or less than 100 mmHg
3. Renal or hepatic dysfunction
4. White blood cell (WBC) count greater than 12,000
5. Chronic inflammatory disease
6. Human Immunodeficiency Virus (HIV)
7. Known sensitivity to ACEI
8. Steroid use
9. Chronic (more than 2 weeks) use of non-steroidal anti-inflammatory drugs (NSAIDs)
10. Treatment with:
a. ACEI or Angiotensin II Receptor Blockers (ARB)
b. Lipid lowering agents
c. Hormone replacement therapy
d. Oral hypoglycemic agents
e. Aspirin
f. Antioxidants
11. Failure to give informed consent

Recruitment start date

01/03/2003

Recruitment end date

30/10/2004

Locations

Countries of recruitment

Canada

Trial participating centre

Div of Cardiac Surgery
Toronto
M5B 1W8
Canada

Sponsor information

Organisation

Sanofi-Aventis (Canada)

Sponsor details

2150 St. Elzear Blvd
Laval
H7L 4A8
Canada

Sponsor type

Industry

Website

http://www.sanofi-aventis.ca

Funders

Funder type

Industry

Funder name

Sanofi-Aventis (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19584979

Publication citations

  1. Results

    Verma S, Lonn EM, Nanji A, Browne K, Ward R, Robertson A, Conradson H, Hildebrand K, Brant R, Anderson TJ, Effect of angiotensin-converting enzyme inhibition on C-reactive protein levels: the ramipril C-reactive pRotein randomized evaluation (4R) trial results., Can J Cardiol, 2009, 25, 7, e236-40.

Additional files

Editorial Notes