Anti Platelet EffectsDOSAPINCT01175200
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
A study testing Clopidogrel, Prasugrel and Lansoprazole in people with Anti Platelet Effects, run by Ascopharm Groupe Novasco at 1 site in France.
Trial summary
This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anti Platelet Effects
- What is being tested?
- Clopidogrel, Prasugrel and Lansoprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with stable Coronary Artery Disease (< 3 months) treated with clopidogrel (75mg/d)
- Between 18 and 75 years of age
- Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
- No major bleeding according to ISTH definition
- Subjects who signed an informed consent document
- Subjects who signed a separate pharmacogenomic informed consent document
- Subjects registered to the French national welfare system
Who cannot join
- Personal or family history of coagulation or bleeding disorders
- Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
- Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
- Known hypersensitivity to clopidogrel / prasugrel
- Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
- Any formal indication to maintain PPI treatment
Show all 11Show fewer
- PPI within 15 days before inclusion in the study
- Active pathology with 10 days before inclusion
- Prior history of stent thrombosis
- Prior history of Stroke
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.
This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.
- Conditions
- Anti Platelet Effects
- Being tested
- Clopidogrel, Prasugrel, Lansoprazole, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
antiplatelet agent
PrasugrelDrug
antiplatelet agent
LansoprazoleDrug
Also called Lanzor, Ogast
proton pum inhibitor
PlaceboDrug
placebo comparator similar to lansoprazole
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Active comparator | Not described Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | Not described Receives: Drug: Clopidogrel |
| Lansoprazole | Active comparator | proton pump inhibitor Receives: Drug: Lansoprazole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antiplatelet effect of clopidogrel
change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina
Measured: 14 days
Secondary outcomes (1)
high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses
compare persistant antiplatelet hyper reactivity in patients with stable angina and treated with clopidogrel or prasugrel associated with lansoprazole (or placebo)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti Platelet EffectsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascopharm Groupe Novasco
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Medco Health Solutions, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175200
- Sponsor's protocol ID
- DOSAPI
- Acronym
- DOSAPI
- Status last verified
- Jul 2012
- First submitted
- 3 Aug 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.
- ClinicalTrials.gov ID
- NCT01175200
- Acronym / sponsor ID
- DOSAPI / DOSAPI
- Conditions
- Anti Platelet Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ascopharm Groupe NovascoUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Medco Health Solutions, Inc.
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Aug 2010 (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.
This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Active comparator | Drug: Prasugrel |
| Clopidogrel | Active comparator | Drug: Clopidogrel |
| Lansoprazole | Active comparator | Drug: Lansoprazoleproton pump inhibitor |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient with stable Coronary Artery Disease (< 3 months) treated with clopidogrel (75mg/d)
- Between 18 and 75 years of age
- Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
- No major bleeding according to ISTH definition
- Subjects who signed an informed consent document
Key exclusion criteria (11 listed)
- Personal or family history of coagulation or bleeding disorders
- Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
- Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
- Known hypersensitivity to clopidogrel / prasugrel
- Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
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 |
|---|---|---|
| Clopidogrelantiplatelet agent | Drug | Clopidogrel |
| Prasugrelantiplatelet agent | Drug | Prasugrel |
| LansoprazoleAlso: Lanzor, Ogastproton pum inhibitor | Drug | Lansoprazole |
| Placeboplacebo comparator similar to lansoprazole | Drug | Placebo |
Primary outcome
Change in antiplatelet effect of clopidogrel
Time frame: 14 days
change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina
1 secondary outcome
high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses
Time frame: 14 days
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 4 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel, Prasugrel and Lansoprazole in people with Anti Platelet Effects, run by Ascopharm Groupe Novasco at 1 site in France.
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 7 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 4 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in antiplatelet effect of clopidogrel (time frame: 14 days). 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 4 Jul 2012.