Myocardial IschemiaPhase 3NCT00268619
FOCUS:Focus On Coronary Unstable Syndromes
A Phase 3 study testing Ramipril in people with Myocardial Ischemia, run by Sanofi.
Trial summary
Study objectives: To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Ramipril
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jul 2005
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study
- Subjects presenting within 12 hours after the last episode of chest pain with:
- An accelerating pattern of anginal pain
- A prolonged or recurrent anginal pain at rest or with minimal effort AND
- Evidence of myocardial ischemia on ECG manifested by at least one of the following ECG criteria: - new persistent or transient ST-segment depression OR transient or reversible ST-segment elevation or new persistent or transient T-wave inversion OR Abnormal cardiac markers defined as: CK-MB greater than the upper limit of normal Troponin T or I level greater than the upper limit of normal.
Who cannot join
- Known or suspected pregnancy or actively breast-feeding
- Female of childbearing potential not using or planning to use a reliable method of contraception
- Treatment with Hormone Replacement Therapy at time of randomization
- Angina precipitated by obvious provoking factors
- Heart Failure defined as known ejection fraction less or equal to 40% or NYHA (New York Heart Association) class III pr IV
- Type I Diabetes Mellitus
Show all 24Show fewer
- Type II diabetes requiring insulin therapy
- Hyperkaliemia
- Acute chronic inflammatory, collagen tissue disease, auto-immune disease or cancer and/or requiring the use of anti-inflammatory or anti-neoplastic agents at the time of randomization
- Use of a non-steriodal anti-inflammatory agent, coxibs, or anti-neoplasic agent within last 7 days
- Use of any oral or intra-venous steroidal agent in the last 7 days before study entry
- Uncontrolled hypertension
- Systolic pressure < 100 mmHg at randomization
- Likelihood of requiring treatment during the study period with drugs not permitted by the protocol
- Treatment with any investigational product or device in the last 4 weeks
- Previous participation into the trial
- History of hypersensitivity, allergy, or intolerance to Angiotensin-Converting Enzyme inhibitors.
- Severe cardiovascular diseases requiring urgent therapy
- Severe or co-morbid condition
- History of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin
- Clinically important systemic disorder
- Impaired hepatic function
- Clinically important chronic or acute renal failure
- History of drug or alcohol abuse
About this study
Official title: A Placebo-controlled, Double-blind, Randomized, Multicenter Study of Ramipril 5 and 10 mg Capsules and Insulin Infusion in Subjects With Unstable Coronary Syndromes
Study objectives:
- To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels.
- To demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an ACS as assessed by Tumor necrosis factor alpha blood levels.
- Conditions
- Myocardial Ischemia
- Being tested
- Ramipril
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the highly specific C-reactive protein (hsCRP) blood levels
Measured: during the study conduct
To assess the tumor necrosing factor alpha (TNFα) blood levels
Measured: during the study conduct
Secondary outcomes (1)
TEAEs collection
Measured: From the signature of the informed consent up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startJun 2004
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stan Glezer, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268619
- Sponsor's protocol ID
- HOE498_3501
- Status last verified
- Jan 2011
- First submitted
- 21 Dec 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Randomized, Multicenter Study of Ramipril 5 and 10 mg Capsules and Insulin Infusion in Subjects With Unstable Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00268619
- Acronym / sponsor ID
- HOE498_3501
- Conditions
- Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2005 (actual)
- First posted
- 22 Dec 2005 (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.
Study objectives:
- To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels.
- To demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an ACS as assessed by Tumor necrosis factor alpha blood levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study
- Subjects presenting within 12 hours after the last episode of chest pain with:
Key exclusion criteria (24 listed)
- Known or suspected pregnancy or actively breast-feeding
- Female of childbearing potential not using or planning to use a reliable method of contraception
- Treatment with Hormone Replacement Therapy at time of randomization
- Angina precipitated by obvious provoking factors
- Heart Failure defined as known ejection fraction less or equal to 40% or NYHA (New York Heart Association) class III pr IV
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 |
|---|---|---|
| Ramipril | Drug | – |
Primary outcome
To assess the highly specific C-reactive protein (hsCRP) blood levels
Time frame: during the study conduct
To assess the tumor necrosing factor alpha (TNFα) blood levels
Time frame: during the study conduct
1 secondary outcome
TEAEs collection
Time frame: From the signature of the informed consent up to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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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.
Stan Glezer study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril in people with Myocardial Ischemia, run by Sanofi.
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 5 inclusion and 24 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: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the highly specific C-reactive protein (hsCRP) blood levels (time frame: during the study conduct). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2011.