Coronary Artery DiseasePhase 2TOPAS-1NCT00914368
Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis
A Phase 2 study testing Clopidogrel in people with Coronary Artery Disease and Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
Trial summary
The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Stent Thrombosis
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Mar 2010
- Phase
- Phase 2
- 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
- Provide signed written informed consent.
- Male or female patients above 18 years old.
- Previous PCI and coronary stenting for coronary artery disease
- Previous (after coronary stenting) or current dual antiplatelet treatment (aspirin 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with aspirin 75 mg once daily at least seven days prior to enrollment.
- Experienced one of the following alternatives:
- Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment; OR
- Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment; OR
- No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control)
Who cannot join
- General exclusion criteria:
- Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
- Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
- Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
- Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).
- Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion.
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- UCR or Accumetrics employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Cardiovascular Exclusion Criteria:
- Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening.
- Subjects with significant hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure >110 mmHg) at the time of screening.
- Bleeding Risk Exclusion Criteria:
- Any known contraindication to treatment with an anticoagulant or antiplatelet agent.
- Prior history or presence of significant bleeding disorders (for example,hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding)
- Prior history or clinical suspicion of cerebral vascular malformations
- Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).
- Personal or family history of coagulation or bleeding disorders.
- Thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (platelet count > 500,000/mm3).
- History of major surgery, severe trauma, organ biopsy within 3 months prior to enrollment.
- Any planned surgical procedure within 20 days following inclusion.
- The use (or planned use) of other antiplatelet agents (besides aspirin and clopidogrel), anticoagulant or fibrinolytic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition
The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.
Read the detailed description
To establish cut off levels of platelet inhibition using ADP-induced P2Y12-receptor mediated platelet aggregation using Accumetrics VerifyNow P2Y12 assay (PRU) and Vasodilator-stimulated phosphoprotein (VASP, PRI %)for patients with experienced stent occlusion with acute clinical onset and/or myocardial infarction within 6 months after coronary stenting for coronary artery disease.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Stent Thrombosis, Heart Diseases, Acute Coronary Syndrome
- Being tested
- Clopidogrel
- Keywords
- Platelet Aggregation Inhibitors, Aspirin, Clopidogrel, Pathologic Processes, Disease, Therapeutic Uses, Syndrome, Hematologic Agents, Cardiovascular Diseases, Pharmacologic Actions
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Heart Diseases, Acute Coronary Syndrome, Pathologic Processes, Disease, Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease Receives: Drug: Clopidogrel |
| 2 | Active comparator | Patients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease Receives: Drug: Clopidogrel |
| 3 | Active comparator | Patients without previously experienced myocardial infarction or stent thrombosis 6 within months after coronary stenting for coronary artery disease(matched controls for group 1 and 2) Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
VerifyNow P2Y12 (PRU)
Measured: Within 6 months
Secondary outcomes (1)
VASP (PRI, %)
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Investigators
- Lars Wallentin, MD, PhD, Principal investigator, Uppsala University, Uppsala Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914368
- Sponsor's protocol ID
- U-08-002
- Acronym
- TOPAS-1
- Status last verified
- Sep 2009
- First submitted
- 29 May 2009
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition
- ClinicalTrials.gov ID
- NCT00914368
- Acronym / sponsor ID
- TOPAS-1 / U-08-002
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Stent Thrombosis, Heart Diseases, Acute Coronary Syndrome
- Keywords
- Platelet Aggregation Inhibitors, Aspirin, Clopidogrel, Pathologic Processes, Disease, Therapeutic Uses, Syndrome, Hematologic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Jun 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.
The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.
Detailed description
To establish cut off levels of platelet inhibition using ADP-induced P2Y12-receptor mediated platelet aggregation using Accumetrics VerifyNow P2Y12 assay (PRU) and Vasodilator-stimulated phosphoprotein (VASP, PRI %)for patients with experienced stent occlusion with acute clinical onset and/or myocardial infarction within 6 months after coronary stenting for coronary artery disease.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ClopidogrelPatients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease |
| 2 | Active comparator | Drug: ClopidogrelPatients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease |
| 3 | Active comparator | Drug: ClopidogrelPatients without previously experienced myocardial infarction or stent thrombosis 6 within months after coronary stenting for coronary artery disease(matched controls for group 1 and 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide signed written informed consent.
- Male or female patients above 18 years old.
- Previous PCI and coronary stenting for coronary artery disease
- Previous (after coronary stenting) or current dual antiplatelet treatment (aspirin 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with aspirin 75 mg once daily at least seven days prior to enrollment.
- Experienced one of the following alternatives:
Key exclusion criteria (20 listed)
- Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
- Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
- Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
- Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).
- Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion.
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 |
|---|---|---|
| ClopidogrelAlso: PlavixPatients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered. | Drug | 1, 2, 3 |
Primary outcome
VerifyNow P2Y12 (PRU)
Time frame: Within 6 months
1 secondary outcome
VASP (PRI, %)
Time frame: Within 6 months
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 13 Apr 2010.
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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.
Lars Wallentin, MD, PhD principal investigator
Uppsala University, Uppsala Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clopidogrel in people with Coronary Artery Disease and Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
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 8 inclusion and 20 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 13 Apr 2010. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
VerifyNow P2Y12 (PRU) (time frame: Within 6 months). 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 13 Apr 2010.