Acute Coronary SyndromePhase 4TERACSNCT00702936
Telmisartan Versus Ramipril After Acute Coronary Syndrome
A Phase 4 study testing TELMISARTAN and RAMIPRIL in people with Acute Coronary Syndrome and Myocardial Infarction, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease
- What is being tested?
- TELMISARTAN and RAMIPRIL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italo Porto, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Catholic University of the Sacred Heart
Rome, 00168
Italo Porto, MD, PhD, i.porto@doctors.org.uk
Luca Di Vito, MD, divitoluca@yahoo.it
About this study
Official title: Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome
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
- Being tested
- TELMISARTAN, RAMIPRIL
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELMISARTANDrug
80 mg daily
RAMIPRILDrug
5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| R | Active comparator | Twenty-five patients assigned to ramipril 5 mg daily Receives: Drug: RAMIPRIL |
| T | Active comparator | Twenty-five patients assigned to Telmisartan 80 mg daily Receives: Drug: TELMISARTAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensitivity C-Reactive Protein
Measured: 20 days after hospital discharge
Secondary outcomes (1)
Endothelial Progenitor Cells
Measured: 20 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Italo Porto, MD, PhD, Principal investigator, Catholic University of the Sacred HeartLuca Di Vito, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702936
- Sponsor's protocol ID
- ILG-1
- Acronym
- TERACS
- Status last verified
- Jun 2008
- First submitted
- 19 Jun 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15831660Liakishev 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.
PubMed 18537808Porto 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.
PubMed 19463506
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00702936
- Acronym / sponsor ID
- TERACS / ILG-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R | Active comparator | Drug: RAMIPRILTwenty-five patients assigned to ramipril 5 mg daily |
| T | Active comparator | Drug: TELMISARTANTwenty-five patients assigned to Telmisartan 80 mg daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TELMISARTAN80 mg daily | Drug | T |
| RAMIPRIL5 mg daily | Drug | R |
Primary outcome
High sensitivity C-Reactive Protein
Time frame: 20 days after hospital discharge
1 secondary outcome
Endothelial Progenitor Cells
Time frame: 20 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Background: PubMed 15831660Biasucci 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 publication: PubMed 18537808Liakishev 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.
- Derived from this study: PubMed 19463506Porto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Italo Porto, MD, PhD contact
Italo Porto, MD, PhD principal investigator
Catholic University of the Sacred Heart
Luca Di Vito, MD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TELMISARTAN and RAMIPRIL in people with Acute Coronary Syndrome and Myocardial Infarction, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Italo Porto, MD, PhD (0039(0)6-30154127, i.porto@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sensitivity C-Reactive Protein (time frame: 20 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.