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Effect of Angiotensin Converting Enzyme Inhibition (ACEI) on C-Reactive Protein (CRP) Levels: The Ramipril CRP Randomized Evaluation (4R Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31129526
Enrollment
400
Registered
2006-01-06
Start date
2003-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers with elevated levels of C-Reactive protein Circulatory System

Interventions

Ramipril 10 mg per day versus placebo for 12 weeks

Sponsors

Sanofi-Aventis (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in CRP levels in Ramipril versus placebo arms

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026