Coronary Heart DiseasePhase 4DOSER-GENERICNCT01147133
Comparison of Generic and Original Formulation of Clopidogrel
A Phase 4 study testing Plavix and Kardogrel in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by University of Pecs.
Trial summary
Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention
- What is being tested?
- Plavix and Kardogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in the maintenance phase of PCI receiving 1x75 mg clopidogrel and 1x100 mg aspirin
- No planned interruption of the antiplatelet therapy in the next 1 month
- Informed consent
Who cannot join
- Oral anticoagulant therapy
- Contraindication for aspirin or clopidogrel
- Planned interruption of antiplatelet therapy in the next month
About this study
Official title: Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI
Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.
Read the detailed description
Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.
In a prospective, cross-over, open-label, unblinded study the investigators aim to compare platelet activation and aggregation between Plavix® and generic clopidogrel.
- Being tested
- Plavix, Kardogrel
- Keywords
- Platelet aggregation, Generic, Clopidogrel, Comparison, VASP-PRI
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlavixDrug
Also called clopidogrel = PLAVIX
1x75 mg
KardogrelDrug
Also called generic clopidogrel = Kardogrel
1x75 mg
| Study group | Role | What they receive |
|---|---|---|
| Original | Experimental | Treatment phase with the original formulation of clopidogrel Receives: Drug: Plavix |
| Generic | Active comparator | Treatment phase with the generic clopidogrel Receives: Drug: Kardogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
Measured: 14 days
Secondary outcomes (1)
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
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 posted22 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Hungarian Academy of Sciences, KRKA
- Responsible party
- Principal investigator, Daniel Aradi MD, University of Pecs
- Investigators
- Daniel Aradi, MD PhD, Principal investigator, University of Pécs, HUNGARYAndrás Komócsi, MD PhD, Study director, University of Pécs, HUNGARY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147133
- Sponsor's protocol ID
- DOSER-GENERIC
- Acronym
- DOSER-GENERIC
- Status last verified
- Jan 2013
- First submitted
- 16 Jun 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI
- ClinicalTrials.gov ID
- NCT01147133
- Acronym / sponsor ID
- DOSER-GENERIC / DOSER-GENERIC
- Keywords
- Platelet aggregation, Generic, Clopidogrel, Comparison, VASP-PRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Hungarian Academy of Sciences, KRKA
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Jun 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.
Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.
Detailed description
Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.
In a prospective, cross-over, open-label, unblinded study the investigators aim to compare platelet activation and aggregation between Plavix® and generic clopidogrel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Original | Experimental | Drug: PlavixTreatment phase with the original formulation of clopidogrel |
| Generic | Active comparator | Drug: KardogrelTreatment phase with the generic clopidogrel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the maintenance phase of PCI receiving 1x75 mg clopidogrel and 1x100 mg aspirin
- No planned interruption of the antiplatelet therapy in the next 1 month
- Informed consent
Key exclusion criteria (3 listed)
- Oral anticoagulant therapy
- Contraindication for aspirin or clopidogrel
- Planned interruption of antiplatelet therapy in the next month
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 |
|---|---|---|
| PlavixAlso: clopidogrel = PLAVIX1x75 mg | Drug | Original |
| KardogrelAlso: generic clopidogrel = Kardogrel1x75 mg | Drug | Generic |
Primary outcome
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point.
Time frame: 14 days
1 secondary outcome
VASP-PRI (%) 6-minute late aggregation with LTA (%) Proportion of patients with high platelet reactivity (HPR)
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 29 Jan 2013.
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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.
Daniel Aradi, MD PhD principal investigator
University of Pécs, HUNGARY
András Komócsi, MD PhD study director
University of Pécs, HUNGARY
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plavix and Kardogrel in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by University of Pecs.
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 3 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
ADP 5 microM-induced maximal aggregation in light transmission aggregometry between the two time point. (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 29 Jan 2013.