NCT01235351

Brief Summary

To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

November 15, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 2, 2010

Results QC Date

December 7, 2012

Last Update Submit

November 13, 2019

Conditions

Myocardial InfarctionPercutaneous Coronary Intervention

Keywords

Myocardial infarctionPercutaneous coronary interventionClopidogrelGeneticsPlatelet Function

Outcome Measures

Primary Outcomes (1)

  • Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)

    The outcome measurement was on-treatment PRI determined through flow cytometric assessment of phosphorylation status of VASP.

    Approximately every 2 weeks for 8 weeks

Study Arms (2)

Clopidogrel - for CYP2C19*2 carriers

ACTIVE COMPARATOR

Clopidogrel for CYP2C19\*2 gene carriers

Drug: Clopidogrel

Clopidogrel - for CYP2C19*2 non-carriers

ACTIVE COMPARATOR

Clopidogrel for CYP2C19\*2 gene NON-carriers

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype

Clopidogrel - for CYP2C19*2 carriers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 and 75 years of age, inclusive.
  • Have an indication for the use of clopidogrel defined as either spontaneous MI \[hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (e.g., due to anemia or hypertensive emergency)\] or PCI within the past 6 months.
  • Clinically stable and at least 4 weeks following the MI or PCI.

You may not qualify if:

  • Conditions that alter platelet function.
  • Conditions that increase bleeding risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TIMI Study Group

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Mega JL, Hochholzer W, Frelinger AL 3rd, Kluk MJ, Angiolillo DJ, Kereiakes DJ, Isserman S, Rogers WJ, Ruff CT, Contant C, Pencina MJ, Scirica BM, Longtine JA, Michelson AD, Sabatine MS. Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. JAMA. 2011 Nov 23;306(20):2221-8. doi: 10.1001/jama.2011.1703. Epub 2011 Nov 16.

    PMID: 22088980RESULT

  • Hochholzer W, Ruff CT, Mesa RA, Mattimore JF, Cyr JF, Lei L, Frelinger AL 3rd, Michelson AD, Berg DD, Angiolillo DJ, O'Donoghue ML, Sabatine MS, Mega JL. Variability of individual platelet reactivity over time in patients treated with clopidogrel: insights from the ELEVATE-TIMI 56 trial. J Am Coll Cardiol. 2014 Jul 29;64(4):361-8. doi: 10.1016/j.jacc.2014.03.051.

    PMID: 25060370RESULT

  • Carreras ET, Hochholzer W, Frelinger AL 3rd, Nordio F, O'Donoghue ML, Wiviott SD, Angiolillo DJ, Michelson AD, Sabatine MS, Mega JL. Diabetes mellitus, CYP2C19 genotype, and response to escalating doses of clopidogrel. Insights from the ELEVATE-TIMI 56 Trial. Thromb Haemost. 2016 Jul 4;116(1):69-77. doi: 10.1160/TH15-12-0981. Epub 2016 Mar 24.

    PMID: 27009617RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Jessica L. Mega, MD, MPH
Organization
TIMI Study Group
jmega@partners.org
6172780145

Study Officials

  • Christian T Ruff, MD, MPH

    The TIMI Study Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 5, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 15, 2019

Results First Posted

November 15, 2019

Record last verified: 2019-11

Locations

US(1)