Arterial Occlusive DiseasesPhase 3NCT00174759
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
A Phase 3 study testing Clopidogrel in people with Arterial Occlusive Diseases, run by Sanofi at 14 sites in 14 countries.
Trial summary
Primary objective: To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Clopidogrel
- How many people
- 1,460 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Sep 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- PAD medical/surgical history
- Onset of PAD symptoms before the age of 40 years
- Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome)
- Patient receiving aorto-bifemoral, iliac-femoral or crossover (femoral-femoral) grafts, or undergoing peripheral transcutaneous angioplasty (PTA), with or without stenting, during the same surgery.
- Medical history related to bleeding risk
- Current active bleeding at surgical site
Show all 15Show fewer
- Withdrawal of an epidural catheter less than 12 hours before randomization
- Current active bleeding or increased risk of bleeding, such as severe hepatic insufficiency, proliferative diabetic retinopathy, peptic ulceration, bleeding diathesis or coagulopathy
- Peptic ulceration within 12 months of randomization
- Previous or current intracranial hemorrhage or hemorrhagic stroke, or any previous stroke for which the diagnosis of hemorrhagic stroke cannot be excluded
- Any history of severe spontaneous bleeding such as gastrointestinal bleeding, gross hematuria, intraocular bleeding
- Other medical conditions
- Previous disabling stroke (severe cerebral deficit such that the patient is bedridden or demented)
- NYHA Class IV heart failure
- Uncontrolled hypertension: Systolic Blood Pressure (SBP) > 180 mm Hg, or Diastolic Blood Pressure (DBP) > 100 mm Hg
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
About this study
Official title: A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.
Primary objective:
To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.
Secondary objectives:
Comparison, between the two treatment groups, of :
- Primary patency,
- Assisted primary patency,
- Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
- Ankle Brachial Pressure Index (ABPI) changes from baseline
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Clopidogrel
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death
Secondary outcomes (1)
1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
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 Arterial Occlusive DiseasesStudies 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
- Enrolment
- 1,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Luc Sagnard, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174759
- Sponsor's protocol ID
- C_9253
- Other IDs
- EudraCT #: 2004-000822-58
- Status last verified
- Jan 2011
- First submitted
- 9 Sep 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Belch JJ, Dormandy J; CASPAR Writing Committee; Biasi GM, Cairols M, Diehm C, Eikelboom B, Golledge J, Jawien A, Lepantalo M, Norgren L, Hiatt WR, Becquemin JP, Bergqvist D, Clement D, Baumgartner I, Minar E, Stonebridge P, Vermassen F, Matyas L, Leizorovicz A. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010 Oct;52(4):825-33, 833.e1-2. doi: 10.1016/j.jvs.2010.04.027. Epub 2010 Aug 1.
PubMed 20678878
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 Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.
- ClinicalTrials.gov ID
- NCT00174759
- Acronym / sponsor ID
- C_9253
- Conditions
- Arterial Occlusive Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2004
- First posted
- 15 Sep 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.
Primary objective:
To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.
Secondary objectives:
Comparison, between the two treatment groups, of :
- Primary patency,
- Assisted primary patency,
- Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
- Ankle Brachial Pressure Index (ABPI) changes from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- PAD medical/surgical history
- Onset of PAD symptoms before the age of 40 years
- Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome)
- Patient receiving aorto-bifemoral, iliac-femoral or crossover (femoral-femoral) grafts, or undergoing peripheral transcutaneous angioplasty (PTA), with or without stenting, during the same surgery.
- Medical history related to bleeding risk
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 | Drug | – |
Primary outcome
1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death
1 secondary outcome
1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
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.
- Derived from this study: PubMed 20678878Belch JJ, Dormandy J; CASPAR Writing Committee; Biasi GM, Cairols M, Diehm C, Eikelboom B, Golledge J, Jawien A, Lepantalo M, Norgren L, Hiatt WR, Becquemin JP, Bergqvist D, Clement D, Baumgartner I, Minar E, Stonebridge P, Vermassen F, Matyas L, Leizorovicz A. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010 Oct;52(4):825-33, 833.e1-2. doi: 10.1016/j.jvs.2010.04.027. Epub 2010 Aug 1.
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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.
Luc Sagnard study director
Sanofi
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel in people with Arterial Occlusive Diseases, run by Sanofi at 14 sites in 14 countries.
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 0 inclusion and 15 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.
Where is the study taking place?
The record lists 14 sites in Australia, Austria, Belgium, Finland, France and 9 more countries. 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?
1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death. 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 NCT00174759, 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 11 Jan 2011.