Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis (TOPAS-1)

This study has been completed.
Sponsor:
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00914368
First received: May 29, 2009
Last updated: April 12, 2010
Last verified: September 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Other Name: Plavix
Active Comparator: 2
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.
Other Name: Plavix
Active Comparator: 3
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.
Other Name: Plavix

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:

  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 < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914368

Locations
Sweden
Uppsala Clinical Research Center
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: Lars Wallentin, MD, PhD. Professor Cardiology, UCR, Uppsala University
ClinicalTrials.gov Identifier: NCT00914368     History of Changes
Other Study ID Numbers: U-08-002
Study First Received: May 29, 2009
Last Updated: April 12, 2010
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

Additional relevant MeSH terms:
Pathologic Processes
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Thrombosis
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Necrosis
Embolism and Thrombosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 20, 2014