Telmisartan Versus Ramipril After Acute Coronary Syndrome (TERACS)

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ClinicalTrials.gov Identifier: NCT00702936

Recruitment Status : Unknown

Verified June 2008 by Catholic University of the Sacred Heart.
Recruitment status was: Recruiting

First Posted : June 20, 2008

Last Update Posted : June 20, 2008

Sponsor:

Information provided by:

Catholic University of the Sacred Heart

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome Myocardial Infarction Coronary Disease	Drug: TELMISARTAN Drug: RAMIPRIL	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome
Study Start Date :	November 2007
Estimated Primary Completion Date :	August 2008
Estimated Study Completion Date :	November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril Telmisartan

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

High sensitivity C-Reactive Protein [ Time Frame: 20 days after hospital discharge ]

Secondary Outcome Measures :

Endothelial Progenitor Cells [ Time Frame: 20 days after hospital discharge ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702936

Contacts

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

Locations

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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

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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

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00702936
Other Study ID Numbers:	ILG-1
First Posted:	June 20, 2008 Key Record Dates
Last Update Posted:	June 20, 2008
Last Verified:	June 2008

Additional relevant MeSH terms:

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Myocardial Infarction Acute Coronary Syndrome Coronary Disease Syndrome Infarction Disease Pathologic Processes Ischemia Necrosis Myocardial Ischemia Heart Diseases	Cardiovascular Diseases Vascular Diseases Telmisartan Ramipril Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors

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