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Telmisartan Versus Ramipril After Acute Coronary Syndrome

NCT ID: NCT00702936

Last Updated: 2008-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Acute Coronary Syndrome Myocardial Infarction Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R

Twenty-five patients assigned to ramipril 5 mg daily

Group Type ACTIVE_COMPARATOR

RAMIPRIL

Intervention Type DRUG

5 mg daily

T

Twenty-five patients assigned to Telmisartan 80 mg daily

Group Type ACTIVE_COMPARATOR

TELMISARTAN

Intervention Type DRUG

80 mg daily

Interventions

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TELMISARTAN

80 mg daily

Intervention Type DRUG

RAMIPRIL

5 mg daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Catholic University of the Sacred Heart

Principal Investigators

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Italo Porto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Luca Di Vito, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

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Catholic University of the Sacred Heart

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Italo Porto, MD, PhD

Role: CONTACT

Phone: 0039(0)6-30154127

Email: [email protected]

Italo Porto, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Italo Porto, MD, PhD

Role: primary

Luca Di Vito, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 15831660 (View on PubMed)

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.

Reference Type RESULT
PMID: 18537808 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19463506 (View on PubMed)

Other Identifiers

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ILG-1

Identifier Type: -

Identifier Source: org_study_id