NCT00702936

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 20, 2008

Status Verified

June 1, 2008

Enrollment Period

9 months

First QC Date

June 19, 2008

Last Update Submit

June 19, 2008

Conditions

Acute Coronary SyndromeMyocardial InfarctionCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • High sensitivity C-Reactive Protein

    20 days after hospital discharge

Secondary Outcomes (1)

  • Endothelial Progenitor Cells

    20 days after hospital discharge

Study Arms (2)

R

ACTIVE COMPARATOR

Twenty-five patients assigned to ramipril 5 mg daily

Drug: RAMIPRIL

T

ACTIVE COMPARATOR

Twenty-five patients assigned to Telmisartan 80 mg daily

Drug: TELMISARTAN

Interventions

TELMISARTANDRUG

80 mg daily

T
RAMIPRILDRUG

5 mg daily

R

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Rome, 00168, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15831660BACKGROUND

  • 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.

    PMID: 18537808RESULT

  • 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.

    PMID: 19463506DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionCoronary Disease

Interventions

TelmisartanRamipril

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Italo Porto, MD, PhD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

  • Luca Di Vito, MD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Italo Porto, MD, PhD

CONTACT

0039(0)6-30154127i.porto@doctors.org.uk

Italo Porto, MD, PhD

CONTACT

italo.porto@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

June 20, 2008

Record last verified: 2008-06

Locations

IT(1)