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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:

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

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

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

Secondary Outcome Measures :
  1. Endothelial Progenitor Cells [ Time Frame: 20 days after hospital discharge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

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
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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00702936     History of Changes
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:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive 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