Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention (ARIVE-PCI) Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01278043
First received: January 10, 2011
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

Subjects in this study have recently had or are scheduled for a percutaneous coronary intervention (PCI) as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.

One complication that can occur after a PCI procedure is blood clotting and narrowing of the artery in the area that was treated. This can result in a decrease in the blood flow to the heart. To avoid this complication, patients are given antiplatelet or "blood-thinning" drugs such as aspirin and clopidogrel as part of their routine care after this procedure.

For this research study, the investigators would like to take blood samples from subjects at 3 different time points while they are taking these antiplatelet drugs. The investigators will study the subjects' blood and medical history to help us further our understanding of how these drugs respond in individuals and in certain patient populations. Everyone responds a little differently to medications due to many reasons including our genetic make-up. Genes are passed down from our parents and determine our physical appearance such as the color of our hair and eyes. Differences in our genes may also help explain why some drugs work in some people, but not in others. By studying subjects' blood, medical history, genetic make-up and by recording how the subjects' blood responds over the course of their treatment, the investigators hope to learn more about how our bodies respond when taking these drugs. Additionally, the investigators hope to find better ways to predict who will respond more effectively to these drugs and better ways to monitor how these drugs are working in patients' bodies over time after PCI procedures.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Incidence, Predictors and Impact of Response Variability to Oral Dual Antiplatelet Therapy, as Measured by Point-of-care Platelet Aggregometry, Following Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • The primary endpoint of the study is occurrence of significant interval thienopyridine response variability and/or inhibition of platelet aggregation (IPA)) measured at study entry vs. 1 week vs. 1 month following oral thienopyridine load. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The co-primary endpoint is occurrence of absolute thienopyridine hyporesponse at any of the specified timepoints. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoint of the study explores the relationship between CYP 2C19 genotypes (ultra-rapid and extensive metabolizers vs. intermediate and poor metabolizers) and thienopyridine response / response variability. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Exploratory analyses will assess correlation between point-of-care platelet aggregometry (VerifyNow) and laboratory-based assessment of platelet function via Light Transmittance Aggregometry (LTA). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Additional analysis will explore the correlation between antiplatelet response to aspirin (ASA) and thienopyridines with incident major adverse cardiac events (MACE) and bleeding events during a 6 month follow-up period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 consecutive patients undergoing PCI at a single medical center will be enrolled in this prospective, open cohort study.

Criteria

Inclusion Criteria:

  • Written informed consent for study participation will be obtained following performance of clinically-indicated PCI
  • 18 years old and up
  • Subjects must have received an oral load of clopidogrel (600 mg total) and aspirin (325 mg if aspirin naïve or minimum 81 mg if on therapy for ≥ 5 days) over the 24 hours preceding enrollment in order to be eligible.

Exclusion Criteria:

  • Patients who are unable or unwilling to provide written informed consent or an accurate medical history,
  • patients unwilling to participate in follow-up,
  • incarcerated or pregnant patients and patients under 18 years of age will be excluded.
  • Additionally patients within 24 hours of discontinuation of eptifibatide or tirofiban infusion or within 2 weeks of abciximab infusion,
  • patients on antiplatelet monotherapy and patients currently on cilostazol or dipyridomole will be excluded as will those likely to discontinue dual antiplatelet therapy during the 6-month follow up.
  • Patients with active bleeding or recent cerebrovascular accident (CVA, "stroke") (≤1 month) at the time of PCI will be excluded, however patients with a history of CVA, bleeding, anemia or thrombocytopenia are eligible providing the clinically-determined careplan includes long-term dual antiplatelet therapy (DAPT).
  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: NCT01278043

Contacts
Contact: Christine Curtis (773) 702-0347 curtis1@uchicago.edu
Contact: Linda Bond (773) 702-6385 lbond@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Christine Curtis    773-702-0347    curtis1@uchicago.edu   
Contact: Linda Bond    (773) 702-6385    lbond@medicine.bsd.uchicago.edu   
Principal Investigator: Sandeep Nathan, MD         
Sub-Investigator: Sandra Weiss, MD         
Sub-Investigator: Neeraj Jolly, MD         
Sub-Investigator: Atman Shah, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Sandeep Nathan, MD University of Chicago
  More Information

No publications provided

Responsible Party: Sandeep Nathan, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT01278043     History of Changes
Other Study ID Numbers: 10-222-A
Study First Received: January 10, 2011
Last Updated: January 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Antiplatelet
Percutaneous Coronary Intervention
Coronary artery disease
Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014