ThrombosisPhase 3CASTLENCT00716924
CASTLE (Clopidogrel And Serum Troponin Level Elevation)
A Phase 3 study testing Clopidogrel in people with Thrombosis, run by Sanofi at 1 site in Mexico.
Trial summary
Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteMexico
- Study dates
- May 2004to Feb 2006
- 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
- Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
- Patients undergoing stent implantation
Who cannot join
- Any known contraindication to the use of aspirin or clopidogrel.
- Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
- Elective administration of IIb/IIIa inhibitors.
- Cardiogenic shock
- Acute MI< 24 hours
- BP systolic <100 mmHg
Show all 13Show fewer
- Left ventricular ejection fraction < 30%
- Heart failure, NYHA class III or IV
- Severe renal insufficiency (creatinine > 3.0 mg/dL)
- Platelet count <100,000/mm³
- Target lesion in a venous bypass graft
- Target lesion in a chronic occlusion
- 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: Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.
- Conditions
- Thrombosis
- Being tested
- Clopidogrel
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
300 mg
ClopidogrelDrug
600 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI Receives: Drug: Clopidogrel |
| 2 | Experimental | 600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI. Receives: Drug: Clopidogrel |
| 3 | Experimental | 600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-percutaneous coronary intervention elevation of troponin T.
Measured: At 6 and 12 months post-PCI
Secondary outcomes (2)
Adverse events.
Measured: From the beginning to the end of the study
Standard hematology and blood chemistry.
Measured: At 6 and 12 months post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Judith Diaz, Md, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716924
- Sponsor's protocol ID
- L_9317
- Acronym
- CASTLE
- Status last verified
- Sep 2009
- First submitted
- 15 Jul 2008
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
- ClinicalTrials.gov ID
- NCT00716924
- Acronym / sponsor ID
- CASTLE / L_9317
- Conditions
- Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2004
- Primary completion
- Feb 2006 (actual)
- First posted
- 16 Jul 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.
Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Clopidogrel300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI |
| 2 | Experimental | Drug: Clopidogrel600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI. |
| 3 | Experimental | Drug: Clopidogrel600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
- Patients undergoing stent implantation
Key exclusion criteria (13 listed)
- Any known contraindication to the use of aspirin or clopidogrel.
- Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
- Elective administration of IIb/IIIa inhibitors.
- Cardiogenic shock
- Acute MI< 24 hours
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 |
|---|---|---|
| Clopidogrel300 mg | Drug | 1 |
| Clopidogrel600 mg | Drug | 2, 3 |
Primary outcome
Incidence of post-percutaneous coronary intervention elevation of troponin T.
Time frame: At 6 and 12 months post-PCI
2 secondary outcomes
Adverse events.
Time frame: From the beginning to the end of the study
Standard hematology and blood chemistry.
Time frame: At 6 and 12 months post-PCI
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 Sep 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.
Judith Diaz, Md 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 in people with Thrombosis, run by Sanofi at 1 site in Mexico.
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 2 inclusion and 13 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 Sep 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 Mexico. 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 post-percutaneous coronary intervention elevation of troponin T. (time frame: At 6 and 12 months post-PCI). 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 Sep 2009; AzTrials last refreshed its copy on 30 Oct 2026.