Stable AnginaPhase 3CLEANNCT00821834
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
A Phase 3 study testing clopidogrel (SR25990) and ticlopidine in people with Stable Angina and Myocardial Infarction, 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 interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stable Angina, Myocardial Infarction
- What is being tested?
- clopidogrel (SR25990) and ticlopidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,003 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2008to Aug 2010
- 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
- Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:
- Myocardial ischemic finding was proven within 2 months before randomization,
- Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
- PCI was being planned.
Who cannot join
- Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
- 3-vessel coronary artery disease with significant lesions in each vessel,
- Planned PCI associated with 6 or more stent placements,
- Not less than 50% stenosis of the left main coronary artery,
- Chronic total occlusion (CTO),
- Saphenous vein graft (SVG).
- 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 Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.
Read more
Secondary objectives:
- To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
- To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
- To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
- To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.
Read the detailed description
The study consisted of two periods:
- a double blind treatment period of 12 weeks followed by,
- an open label clopidogrel treatment period in a subset of patients.
All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
- Conditions
- Stable Angina, Myocardial Infarction
- Being tested
- clopidogrel (SR25990), ticlopidine, Placebo
- Keywords
- Old Myocardial infarction, Platelet Aggregation Inhibitors, Angioplasty, Transluminal, Percutaneous Coronary, Stents
- Medical subject headings
- Angina, Stable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel (SR25990)Drug
Form: tablets
Route: oral
ticlopidineDrug
Form: tablets
Route: oral
PlaceboDrug
Form: tablets
Route: oral
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Patients received:
* clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose,
* ticlopidine matching placebo twice daily. Receives: Drug: clopidogrel (SR25990); Drug: Placebo |
| Ticlopidine | Active comparator | Patients received:
* ticlopidine 100 mg twice daily,
* clopidogrel matching placebo once daily. Receives: Drug: ticlopidine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to first safety events of interest
Safety events of interest were:
- Clinically significant bleeding,
- Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction,
- Elevated liver function values occurring as adverse drug reaction,
- Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
Measured: 12 Weeks (duble blind treatment period)
Secondary outcomes (4)
Time from randomization to first Major Adverse Cardiac Events (MACE)
MACE included:
- All- cause mortality,
- Acute myocardial infarction,
- Revascularization (excluding revascularization related to the planned PCI),
- Stent thrombosis
Measured: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first bleeding events
Measured: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions
Measured: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE included:
- All- cause mortality,
- Acute myocardial infarction,
- Revascularization (excluding revascularization related to the planned PCI),
- Stent thrombosis,
- Ischemic stroke.
Measured: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takaaki Issiki, PhD/FACC, Principal investigator, Division of Cardiology, Dpt of Medicine, Teikyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821834
- Sponsor's protocol ID
- EFC10675
- Acronym
- CLEAN
- Status last verified
- Jul 2011
- First submitted
- 13 Jan 2009
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. 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 Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset
- ClinicalTrials.gov ID
- NCT00821834
- Acronym / sponsor ID
- CLEAN / EFC10675
- Conditions
- Stable Angina, Myocardial Infarction
- Keywords
- Old Myocardial infarction, Platelet Aggregation Inhibitors, Angioplasty, Transluminal, Percutaneous Coronary, Stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jan 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 interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.
Secondary objectives:
- To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
- To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
- To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
- To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.
Detailed description
The study consisted of two periods:
- a double blind treatment period of 12 weeks followed by,
- an open label clopidogrel treatment period in a subset of patients.
All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
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), Drug: PlaceboPatients received: * clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, * ticlopidine matching placebo twice daily. |
| Ticlopidine | Active comparator | Drug: ticlopidine, Drug: PlaceboPatients received: * ticlopidine 100 mg twice daily, * clopidogrel matching placebo once daily. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Myocardial ischemic finding was proven within 2 months before randomization,
- Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
- PCI was being planned.
Key exclusion criteria (7 listed)
- Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
- 3-vessel coronary artery disease with significant lesions in each vessel,
- Planned PCI associated with 6 or more stent placements,
- Not less than 50% stenosis of the left main coronary artery,
- Chronic total occlusion (CTO),
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)Form: tablets Route: oral | Drug | Clopidogrel |
| ticlopidineForm: tablets Route: oral | Drug | Ticlopidine |
| PlaceboForm: tablets Route: oral | Drug | Clopidogrel, Ticlopidine |
Primary outcome
Time from randomization to first safety events of interest
Time frame: 12 Weeks (duble blind treatment period)
Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
4 secondary outcomes
Time from randomization to first Major Adverse Cardiac Events (MACE)
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first bleeding events
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
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 26 Jul 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.
Takaaki Issiki, PhD/FACC principal investigator
Division of Cardiology, Dpt of Medicine, Teikyo 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 Stable Angina and Myocardial Infarction, 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 4 inclusion and 7 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 26 Jul 2011. 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?
Time from randomization to first safety events of interest (time frame: 12 Weeks (duble blind treatment period)). 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 26 Jul 2011.