Telmisartan Versus Ramipril After Acute Coronary Syndrome (TERACS)

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 Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Coronary Disease; Acute Coronary Syndrome
• Intervention / Treatment: Drug: RAMIPRIL; Drug: TELMISARTAN

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Italo Porto, MD, PhD; Phone Number: 0039(0)6-30154127; Email: i.porto@doctors.org.uk
• Study Contact Backup: Name: Italo Porto, MD, PhD; Email: italo.porto@gmail.com

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Catholic University of the Sacred Heart
    • Principal Investigator: Italo Porto, MD, PhD
    • Contact: Italo Porto, MD, PhD; Email: i.porto@doctors.org.uk
    • Contact: Luca Di Vito, MD; Email: divitoluca@yahoo.it
    • Sub-Investigator: Luca Di Vito, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: R; Twenty-five patients assigned to ramipril 5 mg daily	Drug: RAMIPRIL; 5 mg daily
Active Comparator: T; Twenty-five patients assigned to Telmisartan 80 mg daily	Drug: TELMISARTAN; 80 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
High sensitivity C-Reactive Protein	20 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial Progenitor Cells	20 days after hospital discharge

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Italo Porto, MD, PhD, Catholic University of the Sacred Heart; Principal Investigator: Luca Di Vito, MD, Catholic University of the Sacred Heart

Publications and helpful links

General Publications

• 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. doi: 10.1136/hrt.2004.036509. No abstract available.
• Liakishev AA. [Telmisartan, ramipril, or both in patients at high risk for vascular events. Results of the ONTARGET trial]. Kardiologiia. 2008;48(5):72. No abstract available. Russian.
• Porto I, Di Vito L, De Maria GL, Dato I, Tritarelli A, Leone AM, Niccoli G, Capogrossi MC, Biasucci LM, Crea F. Comparison of the effects of ramipril versus telmisartan on high-sensitivity C-reactive protein and endothelial progenitor cells after acute coronary syndrome. Am J Cardiol. 2009 Jun 1;103(11):1500-5. doi: 10.1016/j.amjcard.2009.01.370.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): August 1, 2008
• Study Completion (Anticipated): November 1, 2008

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: June 19, 2008
• First Posted (Estimate): June 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 20, 2008
• Last Update Submitted That Met QC Criteria: June 19, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Myocardial Infarction; Infarction; Coronary Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Telmisartan; Ramipril
• Other Study ID Numbers: ILG-1