Telmisartan Versus Ramipril After Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

— TERACS  

Official title:

Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00702936
• Other study ID #: ILG-1
• Status: Recruiting
• Phase: Phase 4
• First received: June 19, 2008
• Last updated: June 19, 2008
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: June 2008
• Source: Catholic University of the Sacred Heart
• Contact: Italo Porto, MD, PhD
• Phone: 0039(0)6-30154127
• Email: i.porto[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Biasucci LM, Lombardi M, Piro M, Di Giannuario G, Liuzzo G, Crea F. Irbesartan significantly reduces C reactive protein concentrations after 1 month of treatment in unstable angina. Heart. 2005 May;91(5):670-1. — View Citation

Liakishev AA. [Telmisartan, ramipril, or both in patients at high risk for vascular events. Results of the ONTARGET trial]. Kardiologiia. 2008;48(5):72. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High sensitivity C-Reactive Protein		20 days after hospital discharge	No
Secondary	Endothelial Progenitor Cells		20 days after hospital discharge	No

External Links

•   Catholic University