Peripheral Arterial Disease (PAD)Phase 3NCT00862420
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
A Phase 3 study testing clopidogrel (SR25990) and ticlopidine in people with Peripheral Arterial Disease (PAD), run by Sanofi at 1 site in Japan.
Trial summary
Primary objective: To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD) Secondary objectives: To compare the risk of bleeding adverse events, serious adverse events and overall safety of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- clopidogrel (SR25990) and ticlopidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2009to May 2011
- 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
- Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):
- Current intermittent claudication with Ankle Brachial Index (ABI) < 0.90
- A history of intermittent claudication together with previous related intervention in a leg
Who cannot join
- Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
- Bleeding diathesis, coagulopathy and present bleeding disease
- Previous intracranial bleeding or hemorrhagic stroke
- Uncontrolled hypertension
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)
Secondary objectives:
- To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
- To compare the risk of vascular events of clopidogrel with ticlopidine
- To document the long-term safety of clopidogrel for a total of 52 weeks
- To document the vascular events of clopidogrel for a total of 52 weeks
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- clopidogrel (SR25990), ticlopidine
- Keywords
- Platelet aggregation inhibitors, Peripheral arterial disease (PAD)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel (SR25990)Drug
oral administration (tablets)
ticlopidineDrug
oral administration (tablets)
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | 75 mg clopidogrel once daily from Day 1 to Week 12 Receives: Drug: clopidogrel (SR25990) |
| Ticlopidine | Active comparator | 200 mg ticlopidine once daily from Day 1 to Week 12 Receives: Drug: ticlopidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Measured: Week 12 (on treatment)
Secondary outcomes (3)
Bleeding adverse events, Serious adverse events, Overall safety
Measured: Week 12, 52 (on treatment)
Vascular events
Measured: Week 12, 52 (on study)
Safety events of interest (see above)
Measured: Week 52 (on treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease (PAD)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroshi Shigematsu, Head Professor/MD/PhD, Principal investigator, Second Department of Surgery (Vascular Surgery), Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862420
- Sponsor's protocol ID
- SFY10810
- Status last verified
- Jul 2012
- First submitted
- 9 Mar 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039.
PubMed 23555538
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks
- ClinicalTrials.gov ID
- NCT00862420
- Acronym / sponsor ID
- SFY10810
- Conditions
- Peripheral Arterial Disease (PAD)
- Keywords
- Platelet aggregation inhibitors, Peripheral arterial disease (PAD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Mar 2009 (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.
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)
Secondary objectives:
- To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
- To compare the risk of vascular events of clopidogrel with ticlopidine
- To document the long-term safety of clopidogrel for a total of 52 weeks
- To document the vascular events of clopidogrel for a total of 52 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: clopidogrel (SR25990)75 mg clopidogrel once daily from Day 1 to Week 12 |
| Ticlopidine | Active comparator | Drug: ticlopidine200 mg ticlopidine once daily from Day 1 to Week 12 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):
- Current intermittent claudication with Ankle Brachial Index (ABI) < 0.90
- A history of intermittent claudication together with previous related intervention in a leg
Key exclusion criteria (5 listed)
- Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
- Bleeding diathesis, coagulopathy and present bleeding disease
- Previous intracranial bleeding or hemorrhagic stroke
- Uncontrolled hypertension
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 (SR25990)oral administration (tablets) | Drug | Clopidogrel |
| ticlopidineoral administration (tablets) | Drug | Ticlopidine |
Primary outcome
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Time frame: Week 12 (on treatment)
3 secondary outcomes
Bleeding adverse events, Serious adverse events, Overall safety
Time frame: Week 12, 52 (on treatment)
Vascular events
Time frame: Week 12, 52 (on study)
Safety events of interest (see above)
Time frame: Week 52 (on treatment)
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 17 Jul 2012.
- Derived from this study: PubMed 23555538Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039.
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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.
Hiroshi Shigematsu, Head Professor/MD/PhD principal investigator
Second Department of Surgery (Vascular Surgery), Tokyo Medical University
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 (SR25990) and ticlopidine in people with Peripheral Arterial Disease (PAD), 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 3 inclusion and 5 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 17 Jul 2012. 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?
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...) (time frame: Week 12 (on treatment)). 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 NCT00862420, which also lists 1 linked publication.
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 17 Jul 2012.