Telmisartan Versus Ramipril After Acute Coronary Syndrome - Full Text View

Telmisartan Versus Ramipril After Acute Coronary Syndrome (TERACS)

This study is currently recruiting participants.

Verified by Catholic University of the Sacred Heart, June 2008

First Received: June 19, 2008 No Changes Posted

Sponsor:	Catholic University of the Sacred Heart
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00702936

Purpose

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

Condition	Intervention	Phase
Acute Coronary Syndrome Myocardial Infarction Coronary Disease	Drug: TELMISARTAN Drug: RAMIPRIL	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Ramipril Telmisartan

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

High sensitivity C-Reactive Protein [ Time Frame: 20 days after hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endothelial Progenitor Cells [ Time Frame: 20 days after hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
R: Active Comparator Twenty-five patients assigned to ramipril 5 mg daily	Drug: RAMIPRIL 5 mg daily
T: Active Comparator Twenty-five patients assigned to Telmisartan 80 mg daily	Drug: TELMISARTAN 80 mg daily

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702936

Contacts

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

Locations

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

Sponsors and Collaborators

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

More Information

Additional Information:

Catholic University This link exits the ClinicalTrials.gov site

Publications:

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. No abstract available.

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. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Catholic University of the Sacred Heart ( Catholic University of the Sacred Heart )
Study ID Numbers:	ILG-1
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702936 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Arteriosclerosis
Ramipril
Necrosis
Pathologic Processes
Therapeutic Uses
Syndrome
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Myocardial Infarction
Arterial Occlusive Diseases
Heart Diseases

Disease
Vascular Diseases
Enzyme Inhibitors
Ischemia
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Coronary Disease
Acute Coronary Syndrome
Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010