Platelet Aggregation InhibitorsPhase 3NCT00325390
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation
A Phase 3 study testing clopidogrel (SR25990C) in people with Platelet Aggregation Inhibitors and NSTEACS, run by Sanofi at 1 site in Japan.
Trial summary
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Platelet Aggregation Inhibitors, NSTEACS
- What is being tested?
- clopidogrel (SR25990C)
- How many people
- 800 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2004to not given
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:
- (1)Clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration).
- (2)Patients who meet either of following criteria
- ECG changes compatible with new ischemia [e.g. ST depression (at least 1 mm), T wave inversion (at least 2 mm), or hyperacute peaked T waves in 2 contiguous leads].
- already elevated CK at least twice the upper limit of normal or CK-MB or Troponin I or T above the upper limit of normal or positive qualitative test for Troponin T.
- (3)A percutaneous coronary intervention is planned within 96 hours after the first study drug administration
Who cannot join
- A)Factors that affect participation in study:
- (1)Previous disabling stroke
- (2)Previous intracranial hemorrhage or hemorrhagic stroke
- (3)Severe co-morbid condition such that the patient is not expected to survive 1 month
- (4)NYHA Class IV heart failure
- (5)Uncontrolled hypertension
Show all 11Show fewer
- (6)Requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or NSAIDs (excluding unum sumatur), during study period,
- B)Factors related to ASA and/or ticlopidine treatment:
- (1)Use of ticlopidine within 1 week prior to randomization
- (2)History of ASA or ticlopidine intolerance or allergy
- (3)Contraindications to ASA or ticlopidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).
- Conditions
- Platelet Aggregation Inhibitors, NSTEACS
- Being tested
- clopidogrel (SR25990C)
- Keywords
- SR25990C, Platelet Aggregation Inhibitors, NSTEACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel (SR25990C)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of effficacy and safety events
Secondary outcomes (1)
Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Aggregation InhibitorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Pharmaceuticals
- Investigators
- Yuko HARADA, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325390
- Sponsor's protocol ID
- EFC6720
- Status last verified
- Mar 2009
- First submitted
- 11 May 2006
- Last updated
- 25 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00325390
- Acronym / sponsor ID
- EFC6720
- Conditions
- Platelet Aggregation Inhibitors, NSTEACS
- Keywords
- SR25990C, Platelet Aggregation Inhibitors, NSTEACS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Pharmaceuticals
- Study start
- Jul 2004
- First posted
- 12 May 2006 (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.
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:
Key exclusion criteria (11 listed)
- A)Factors that affect participation in study:
- B)Factors related to ASA and/or ticlopidine treatment:
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 |
|---|---|---|
| clopidogrel (SR25990C) | Drug | – |
Primary outcome
Incidence of effficacy and safety events
1 secondary outcome
Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・
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 25 Mar 2009.
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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.
Yuko HARADA study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clopidogrel (SR25990C) in people with Platelet Aggregation Inhibitors and NSTEACS, run by Sanofi at 1 site in Japan.
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 6 inclusion and 11 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 25 Mar 2009. 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 Japan. 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 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?
Incidence of effficacy and safety events. 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 25 Mar 2009.