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Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis (TOPAS-1)
This study is currently recruiting participants.
Verified by Uppsala University, June 2009
First Received: May 29, 2009   Last Updated: June 4, 2009   History of Changes
Sponsored by: Uppsala University
Information provided by: Uppsala University
ClinicalTrials.gov Identifier: NCT00914368
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Myocardial Infarction
Stent Thrombosis
Heart Diseases
Acute Coronary Syndrome
Drug: Clopidogrel
Phase II

Study Type: Interventional
Study Design: Screening, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title: TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • VerifyNow P2Y12 (PRU) [ Time Frame: Within 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VASP (PRI, %) [ Time Frame: Within 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Patients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease
Drug: Clopidogrel
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.
2: Active Comparator
Patients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease
Drug: Clopidogrel
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.
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)
Drug: Clopidogrel
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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, in another investigational device 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914368

Contacts
Contact: Susanne Heller, PhD +46 18 611 95 51 susanne.heller@ucr.uu.se
Contact: Christoph Varenhorst, MD +46 73 201 67 67 christoph.varenhorst@ucr.uu.se

Locations
Sweden
Uppsala Clinical Research Center Recruiting
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Lars Wallentin, MD, PhD Uppsala University, Uppsala Clinical Research Center
  More Information

No publications provided

Responsible Party: UCR, Uppsala University ( Lars Wallentin, MD, PhD. Professor Cardiology )
Study ID Numbers: U-08-002
Study First Received: May 29, 2009
Last Updated: June 4, 2009
ClinicalTrials.gov Identifier: NCT00914368     History of Changes
Health Authority: Sweden: Medical Products Agency;   Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Platelet Aggregation Inhibitors
Aspirin
Clopidogrel
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Thrombosis
Coronary Disease
Embolism and Thrombosis
Necrosis
Aspirin
Embolism
Clopidogrel
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Disease
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Ischemia
Arteriosclerosis
Pharmacologic Actions
Thrombosis
Coronary Disease
Embolism and Thrombosis
Necrosis
Pathologic Processes
Therapeutic Uses
Clopidogrel
Syndrome
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 03, 2009