TAILORING OF PLATELET INHIBITION TO AVOID STENT THROMBOSIS TOPAS-1A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition - TOPAS-1

• Conditions: Previous patients in the TABR study treated with Plavix 75 mg/dayand 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: 9.1Level: LLTClassification code 10063933Term: Coronary stent thrombosis

• Registration Number: EUCTR2008-005491-27-SE
• Lead Sponsor: CR Uppsala Clinical Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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:
7Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening.
8Subjects with significant hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure >110 mmHg) at the time of screening.
Bleeding Risk Exclusion Criteria:
9Any 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 < 100,000/mm3) or thrombocytosis (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified