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Telmisartan Versus Ramipril After Acute Coronary Syndrome (TERACS)

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
TELMISARTAN
RAMIPRIL
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of the Sacred HeartRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

R

T

Arm Description

Twenty-five patients assigned to ramipril 5 mg daily

Twenty-five patients assigned to Telmisartan 80 mg daily

Outcomes

Primary Outcome Measures

High sensitivity C-Reactive Protein

Secondary Outcome Measures

Endothelial Progenitor Cells

Full Information

First Posted
June 19, 2008
Last Updated
June 19, 2008
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00702936
Brief Title
Telmisartan Versus Ramipril After Acute Coronary Syndrome
Acronym
TERACS
Official Title
Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R
Arm Type
Active Comparator
Arm Description
Twenty-five patients assigned to ramipril 5 mg daily
Arm Title
T
Arm Type
Active Comparator
Arm Description
Twenty-five patients assigned to Telmisartan 80 mg daily
Intervention Type
Drug
Intervention Name(s)
TELMISARTAN
Intervention Description
80 mg daily
Intervention Type
Drug
Intervention Name(s)
RAMIPRIL
Intervention Description
5 mg daily
Primary Outcome Measure Information:
Title
High sensitivity C-Reactive Protein
Time Frame
20 days after hospital discharge
Secondary Outcome Measure Information:
Title
Endothelial Progenitor Cells
Time Frame
20 days after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Italo Porto, MD, PhD
Phone
0039(0)6-30154127
Email
i.porto@doctors.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Italo Porto, MD, PhD
Email
italo.porto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Porto, MD, PhD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luca Di Vito, MD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Italo Porto, MD, PhD
Email
i.porto@doctors.org.uk
First Name & Middle Initial & Last Name & Degree
Luca Di Vito, MD
Email
divitoluca@yahoo.it
First Name & Middle Initial & Last Name & Degree
Italo Porto, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luca Di Vito, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15831660
Citation
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.
Results Reference
background
PubMed Identifier
18537808
Citation
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.
Results Reference
result
PubMed Identifier
19463506
Citation
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.
Results Reference
derived

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Telmisartan Versus Ramipril After Acute Coronary Syndrome

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