Official Title: “Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome”

The purpose of this study is to compare the antinflammatory and endothelial progenitor cell (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute coronary syndrome

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: TELMISARTAN
  • 80 mg daily
• Drug: RAMIPRIL
  • 5 mg daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: R
  • Twenty-five patients assigned to ramipril 5 mg daily
• Active Comparator: T
  • Twenty-five patients assigned to Telmisartan 80 mg daily

Primary Measures

• High sensitivity C-Reactive Protein
  • Time Frame: 20 days after hospital discharge
    Safety Issue?: No

Secondary Measures

• Endothelial Progenitor Cells
  • Time Frame: 20 days after hospital discharge
    Safety Issue?: No

Inclusion Criteria:

• Biochemical evidence of myocardial infarction as indicated by elevation of cTnT,
• presence of ECG ischemic changes,
• angiographic evidence of a primary coronary event, such as plaque erosion and/or rupture, fissuring, or dissection at coronary angiography,
• successful coronary revascularization of at least one culprit coronary vessel.

Exclusion Criteria:

• Age>80 years, current ACE inhibitor or ARB treatment,
• ejection fraction <35%, infarction secondary to ischemia due to an imbalance of O2 supply and demand,
• ECG abnormalities that could affect the recognition of ST segment shift,
• recent or chronic infective or inflammatory diseases,
• malignancy, and myocardial infarction,
• surgery or trauma in the previous month.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Catholic University of the Sacred Heart

Overall Clinical Trial Officials and Contacts

Italo Porto, MD, PhD Principal Investigator Catholic University of the Sacred Heart  

Overall Contact: Italo Porto, MD, PhD 0039(0)6-30154127 i.porto@doctors.org.uk

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702936

Study ID Number: ILG-1

ClinicalTrials.gov Identifier: NCT00702936

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Catholic University