NCT00998127

Brief Summary

The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,031

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
5 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

October 16, 2009

Last Update Submit

February 10, 2016

Conditions

Medication Non-adherenceStent Thrombosis

Keywords

Dual Anti-Platelet TherapyNon-adherenceMACENACE

Outcome Measures

Primary Outcomes (12)

  • Incidence of Anti-platelet agent discontinuation/ interruption/ disruption

    at 1 month

  • Incidence of Anti-platelet agent discontinuation/ interruption/ disruption

    at 6 months

  • Incidence of Anti-platelet agent discontinuation/ interruption/ disruption

    at 12 months

  • Incidence of Anti-platelet agent discontinuation/ interruption/ disruption

    at 24 months

  • Incidence of major and minor bleeding (according to TIMI and ACUITY definitions)

    at 1 month

  • Incidence of major and minor bleeding (according to TIMI and ACUITY definitions)

    at 6 months

  • Incidence of major and minor bleeding (according to TIMI and ACUITY definitions)

    at 12 months

  • Incidence of major and minor bleeding (according to TIMI and ACUITY definitions)

    at 24 months

  • Incidence of definite and/or probable stent thrombosis (ARC definition)

    at 1 month

  • Incidence of definite and/or probable stent thrombosis (ARC definition)

    at 6 months

  • Incidence of definite and/or probable stent thrombosis (ARC definition)

    at 12 months

  • Incidence of definite and/or probable stent thrombosis (ARC definition)

    at 24 months

Secondary Outcomes (8)

  • Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.)

    at 1 month

  • Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.)

    at 6 months

  • Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.)

    at 12 months

  • Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.)

    at 24 months

  • Incidence of NACE (NACE is defined as the composite of cardiac death, MI (Q and non-Q-wave), ischemia driven revascularization of the target lesion and major bleeding (ACUITY criteria).)

    at 1 month

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects in any of the participating US or European sites who have undergone successful stent implantation in a native coronary artery.

You may qualify if:

  • The subject has been informed of the nature of the study, agrees to its provisions, and has signed and been provided an "Informed Consent Form" approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
  • The subject must be ≥18 of age (or minimum age as required by local regulations) at the time of enrollment with successful stent placement in one or more lesions in native coronary arteries using an approved coronary stent.
  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV), OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III), OR subjects with documented silent ischemia, OR acute myocardial infarction.
  • The subject is willing and able to cooperate with the study procedures and required follow-ups.

You may not qualify if:

  • Subjects with hypersensitivity or allergies to anti-platelet therapy.
  • Subjects in whom anti-platelet and/or anticoagulation therapy is contraindicated.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following the index procedure.
  • The subject is participating in an investigational device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
  • Subject has a history of bleeding diathesis or coagulopathy.
  • Subject has other medical illness (e.g., cancer, known malignancy or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the followups as defined by the protocol or confound the data interpretation.
  • Evidence of stent thrombosis by visual angiographic assessment during the index procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Saint Luke's/ Mid-America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Geisinger Medical Center Clinic

Danville, Pennsylvania, 17822, United States

Location

Hopital Bichat

Paris, 75877, France

Location

Charite - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Onassis Cardiac Surgery Center

Athens, 176 74, Greece

Location

Careggi Hospital

Florence, 50134, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (4)

  • Baber U, Leisman DE, Cohen DJ, Gibson CM, Henry TD, Dangas G, Moliterno D, Kini A, Krucoff M, Colombo A, Chieffo A, Sartori S, Witzenbichler B, Steg PG, Pocock SJ, Mehran R. Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk. Circ Cardiovasc Qual Outcomes. 2019 Jan;12(1):e004945. doi: 10.1161/CIRCOUTCOMES.118.004945.

    PMID: 30606052DERIVED

  • Shah B, Baber U, Pocock SJ, Krucoff MW, Ariti C, Gibson CM, Steg PG, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Iakovou I, Dangas G, Aquino MB, Sartori S, Chieffo A, Moliterno DJ, Colombo A, Mehran R. White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era: Insights From the PARIS Study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry). Circ Cardiovasc Interv. 2017 Sep;10(9):e004981. doi: 10.1161/CIRCINTERVENTIONS.117.004981.

    PMID: 28916600DERIVED

  • Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, Ariti C, Litherland C, Dangas G, Gibson CM, Krucoff MW, Moliterno DJ, Kirtane AJ, Stone GW, Colombo A, Chieffo A, Kini AS, Witzenbichler B, Weisz G, Steg PG, Pocock S. Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS. J Am Coll Cardiol. 2016 May 17;67(19):2224-2234. doi: 10.1016/j.jacc.2016.02.064. Epub 2016 Apr 11.

    PMID: 27079334DERIVED

  • Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013 Nov 23;382(9906):1714-22. doi: 10.1016/S0140-6736(13)61720-1. Epub 2013 Sep 1.

    PMID: 24004642DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Roxana Mehran, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Antonio Colombo, MD

    San Raffaele Hospital (Milan, Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 20, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

US(10)GR(1)DE(1)IT(2)FR(1)