Telmisartan Versus Ramipril After Acute Coronary Syndrome (TERACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00702936
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional 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
Study First Received: June 19, 2008
Last Updated: June 19, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Syndrome
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Disease
Arteriosclerosis
Arterial Occlusive Diseases
Ramipril
Telmisartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014