Evaluation and Comparison of Several Point-of-Care Platelet Function Tests in Predicting Clinical Outcomes in Clopidogrel Pre-Treated Patients Undergoing Elective PCI.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by R&D Cardiologie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00352014
First received: July 13, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

The purpose of this study is to investigate whether the level of Platelet Inhibition as assessed with five point-of-care platelet function assays correlates with clinical (periprocedural) outcomes such as Acute Myocardial Infarction, death, Target Vessel revascularization and/or stroke in patients undergoing elective PCI.


Condition
Stable Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Do Point-of-Care Platelet Function Assays Predict Clinical Outcomes in Clopidogrel Pre-Treated Patients Undergoing Elective PCI. (The POPular Study)

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

Estimated Enrollment: 1000
Study Start Date: January 2006
Estimated Study Completion Date: May 2008
Detailed Description:

Antiplatelet agents—aspirin, thienopyridines, and platelet glycoprotein IIb/IIIa (GpIIb/IIIa) inhibitors—have become cornerstones in the treatment of ischemic heart disease for patients undergoing percutaneous coronary intervention (PCI)1,2. However, several studies have demonstrated with the use of platelet function assays that subgroups of patients receiving either aspirin, clopidogrel, or both fail to produce the anticipated antiplatelet effect3-5. Consequently, terms like “aspirin-resistance” and “clopidogrel resistance” have been introduced in literature.

Light transmittance platelet aggregometry is generally considered to be the gold standard for determining platelet function, but its relevance to in vivo platelet function is questionable and the logistically demands of the method make it impossible to use in daily practice. In addition, aggregation is just one of several important platelet functions. The introduction of several point-of-care assays may be the key to the widespread clinical use of platelet function testing to identify so called anti-platelet therapy low-responders. However, whether these point-of-care platelet function tests provide predictive value (i.e. correlate with clinical outcomes) and the allocation of the “best” or most suitable point-of-care Platelet function assay to determine the level of inhibition of platelet function remains to be established.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery disease with objective evidence of ischemia (e.g., symptoms of angina pectoris, positive results of a stress test or dynamic electrocardiographic [ECG] changes)
  • Adequate Aspirin and Clopidogrel pre-treatment.( Adequate clopidogrel pre-treatment is defined as a 600 mg loading dose of clopidogrel at least 6 hours prior to the PCI-procedure or a 300 mg loading dose of clopidogrel >24 hours prior to the PCI-procedure or a 75 mg dose of clopidogrel for at least >5 days prior to the PCI procedure
  • Patient is thought to be at a high likelihood for requiring PCI (significant angiographic lesions in native coronary arteries amenable to and requiring a percutaneous coronary intervention)
  • A stent (either drug-eluting or bare metal) is planned to be placed in at least one lesion.
  • Written Informed consent

Exclusion Criteria:

  • ST-segment elevation Acute Myocardial Infarction (ST-segment ≥0.1mV in ≥2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
  • Contraindications to antithrombotic/antiplatelet therapy
  • Failed coronary intervention in the previous 2 weeks
  • Malignancies
  • Increased risk of bleeding (previous stroke in the past months, active bleeding or bleeding diathesis, recent trauma or major surgery in the last month, suspected aortic dissection, oral anticoagulation therapy with coumarin derivate within 7 days, recent use of GPIIb/IIIa inhibitors within 14 days, severe uncontrolled hypertension >180 mmHg unresponsive to therapy)
  • Relevant hematologic deviations (hemoglobin <100g/L (6,2 mmol/L) or hematocrit <34%, platelet count <100 x 109 /L or platelet count > 600 x 109/L)
  • Known allergy to clopidogrel
  • Pregnancy (present or suspected)
  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: NCT00352014

Contacts
Contact: Jurrien M. ten Berg, MD, PhD 0031-30-6099111 berg03@antonius.net
Contact: Jochem W. van Werkum, MD 0031-30-609111 w.van.werkum@antonius.net

Locations
Netherlands
Department of Cardiology, St. Antonius Hospital, The Netherlands Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: Jurrien M ten Berg, MD, PhD    0031-31-6099111    berg03@antonius.net   
Contact: Jochem W van Werkum, MD    0031-30-6099111    w.van.werkum@antonius.net   
Sub-Investigator: Jochem W van Werkum, MD         
Sub-Investigator: Christian M Hackeng, PhD         
Sponsors and Collaborators
R&D Cardiologie
Investigators
Principal Investigator: Jurrien M ten Berg, MD, PhD Department of Cardiology, St. Antonius Hospital Nieuwegein, The Netherlands
Study Chair: Jochem W van Werkum, MD Department of Research and Development in Cardiology, St. Antonius Hospital Nieuwegein, The Netherlands
Study Chair: Christian M Hackeng, PhD Department of Clinical Chemistry, Nieuwegein, St. Antonius Hospital The Netherlands
  More Information

No publications provided by R&D Cardiologie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00352014     History of Changes
Other Study ID Numbers: Z-05.13
Study First Received: July 13, 2006
Last Updated: July 13, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by R&D Cardiologie:
Monitoring of antiplatelet therapy
antiplatelet therapy
platelet function assays
Aspirin
Clopidogrel
elective PCI

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014