Effect of Angiotensin Converting Enzyme Inhibition (ACEI) on C-Reactive Protein (CRP) Levels: The Ramipril CRP Randomized Evaluation (4R Trial)
| ISRCTN | ISRCTN31129526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31129526 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/12/2005
- Registration date
- 06/01/2006
- Last edited
- 20/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Subodh Verma
Scientific
Scientific
Div of Cardiac Surgery
St. Michael's Hospital
University of Toronto
30 Bond Street
Toronto
M5B 1W8
Canada
Study information
| Study design | Randomized double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Yes, approved by Institutional Review Board University of Calgary, Faculty of Medicine February 2003 (2003020012Ram) |
| Condition | Healthy volunteers with elevated levels of C-Reactive protein |
| Intervention | Ramipril 10 mg per day versus placebo for 12 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ramipril |
| Primary outcome measure | 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 study start date | 01/03/2003 |
| Overall study end date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 35-80 years of age, male or female, free of cardiovascular disease, and baseline CRP greater than 2 mg/l |
| 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
Study participating centre
Div of Cardiac Surgery
Toronto
M5B 1W8
Canada
M5B 1W8
Canada
Sponsor information
Sanofi-Aventis (Canada)
Industry
Industry
2150 St. Elzear Blvd
Laval
H7L 4A8
Canada
| Website | http://www.sanofi-aventis.ca |
|---|---|
"ROR" |
https://ror.org/01aptcd74 |
Funders
Funder type
Industry
Sanofi-Aventis (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
