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

NCT00352014 | Completed

• 1 other identifier: Z-05.13
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stable Angina Pectoris

Keywords

Monitoring of antiplatelet therapy; antiplatelet therapy; platelet function assays; Aspirin; Clopidogrel; elective PCI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• R&D Cardiologie: lead

Study Sites (1)

Department of Cardiology, St. Antonius Hospital, The Netherlands

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (3)

• Bouman HJ, Harmsze AM, van Werkum JW, Breet NJ, Bergmeijer TO, Ten Cate H, Hackeng CM, Deneer VH, Ten Berg JM. Variability in on-treatment platelet reactivity explained by CYP2C19*2 genotype is modest in clopidogrel pretreated patients undergoing coronary stenting. Heart. 2011 Aug;97(15):1239-44. doi: 10.1136/hrt.2010.220509. Epub 2011 May 31.

  PMID: 21628721 DERIVED

• Breet NJ, van Werkum JW, Bouman HJ, Kelder JC, Harmsze AM, Hackeng CM, ten Berg JM. High on-treatment platelet reactivity to both aspirin and clopidogrel is associated with the highest risk of adverse events following percutaneous coronary intervention. Heart. 2011 Jun;97(12):983-90. doi: 10.1136/hrt.2010.220491. Epub 2011 Apr 8.

  PMID: 21478385 DERIVED

• Breet NJ, van Werkum JW, Bouman HJ, Kelder JC, Ruven HJ, Bal ET, Deneer VH, Harmsze AM, van der Heyden JA, Rensing BJ, Suttorp MJ, Hackeng CM, ten Berg JM. Comparison of platelet function tests in predicting clinical outcome in patients undergoing coronary stent implantation. JAMA. 2010 Feb 24;303(8):754-62. doi: 10.1001/jama.2010.181.

  PMID: 20179285 DERIVED

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jurrien M ten Berg, MD, PhD

  Department of Cardiology, St. Antonius Hospital Nieuwegein, The Netherlands

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

NL (1)