Previous patients in the TABR study treated with Plavix 75 mg/day and patients with stent thrombosis within 6 months or myocardial infarction within 6 month after stenting. For the control group none of these events after stenting. MedDRA version: 9.1 Level: LLT Classification code 10063933 Term: Coronary stent thrombosis
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Film-coated tablet
Sponsors
UCR Uppsala Clinical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient group 1 – validation part. Patients fulfil inclusion criteria if they provide signed informed consent and have previously been randomised to clopidogrel treatment in the TABR study. Patient groups 2 and 3 Patients must fulfil the following inclusion criteria to be included: 1. Provide signed written informed consent. 2. Male or female patients above 18 years old. 3. Previous PCI and coronary stenting for coronary artery disease 4. Previous (after coronary stenting) or current dual antiplatelet treatment (ASA 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with ASA 75 mg once daily at least seven days prior to enrollment. and experienced one of the following alternatives: 5. a) Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment. or b) Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment. or c) No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding. 2. Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion 3. 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. 4. Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine). 5. Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator’s opinion. 6. 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: 7 Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening. 8 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: 9 Any known contraindication to treatment with an anticoagulant or antiplatelet agent. 10. Prior history or presence of significant bleeding disorders (for example,hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding) 11. Prior history or clinical suspicion of cerebral vascular malformations 12. Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure). 13. Personal or family history of coagulation or bleeding disorders. 14. Thrombocytopenia (platelet count 500,000/mm3). 15. History of major surgery, severe trauma, organ biopsy within 3 months prior to enrollment. 16. Any planned surgical procedure within 20 days following inclusion. 17. The use (or planned use) of other antiplatelet agents (besides aspirin and clopidogrel), anticoagulant or fibrinolytic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to establish a cut-off level of P2Y12 inhibition measured with VerifyNow that separates patients with a high and low risk of stent thrombosis during acethyl salicylic acid (ASA) and clopidogrel treatment during 6 months after stenting for coronary artery disease. The hyptothesis is to identify a level below which less than 10 % of the patients with stent thrombosis should have their results. The primary variable is the level of P2Y12 measured on Visit 2 (day 7-10) for the clopidogrel naïve patients and the single measurement for patients already on maintenance treatment with clopidogrel 75 mg o.d.;Secondary Objective: 1.To establish cut-off levels of P2Y12 inhibition measured within 6 months after stenting for coronary artery disease with; VerifyNow in patients with recurrent myocardial infarction. VerifyNow in patients with definite stent thrombosis and/or recurrent myocardial infarction VASP in patients with definite stent thrombosis. VASP in patients with recurrent myocardial infarction. VASP in patients with definite stent trombosis and/or recurrent myocardial infarction 2.To evaluate the propotions of patients without definite stent trombosis or recurrent myocardial infarction that will be above and below the established cut-off levels mentioned above. 3.To evaluate the relationship of the mesurements on different timepoints of P2Y12 inhibition in clopidogrel naïve patients 4.To analyse biomarkers at the same time-point as above such as 5.To valuate relations between genetic variation and clopidogrel reponsiveness and risk for stent thrombosis ;Primary end point(s): The primary objective of the trial is to establish a cut-off level of P2Y12 inhibition measured with VerifyNow™ P2Y12 that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin (ASA) and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease. Less than 10 % of the patients | — |
Countries
Sweden
Outcome results
None listed