NCT01586975

Brief Summary

The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_2 stroke

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

July 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

December 3, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

August 3, 2011

Results QC Date

June 29, 2015

Last Update Submit

December 2, 2015

Conditions

StrokeMyocardial Infarctions

Outcome Measures

Primary Outcomes (1)

  • PFA1

    Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as \<172 seconds."

    3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)

Study Arms (3)

Clopidogrel 75 mg

ACTIVE COMPARATOR

Clopidogrel 75 mg daily

Drug: Clopidogrel

Aspirin 81 mg

ACTIVE COMPARATOR

open-label Aspirin 81 mg daily

Drug: Aspirin 81 mg

Aspirin > 300mg

ACTIVE COMPARATOR

open-label Aspirin over 300 mg daily

Drug: Aspirin >300 mg

Interventions

ClopidogrelDRUG

Clopidogrel 75 mg QD

Also known as: Plavix
Clopidogrel 75 mg
Aspirin 81 mgDRUG

Aspirin 81mg QD

Also known as: Acetylsalicylic Acid, ASA
Aspirin 81 mg
Aspirin >300 mgDRUG

Aspirin \>300 mg QD

Also known as: Acetylsalicylic Acid, ASA
Aspirin > 300mg

Eligibility Criteria

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

You may qualify if:

  • Patient must be taking Aspirin or Plavix
  • Patient must have had a stroke, TIA or cerebrovascular disease

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.

    PMID: 8784113BACKGROUND

MeSH Terms

Conditions

StrokeMyocardial Infarction

Interventions

ClopidogrelAspirin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Northwestern University
Organization
Northwestern University
r-bernstein@northwestern.edu
312.503.4394

Study Officials

  • Mark J Alberts, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

April 27, 2012

Study Start

July 1, 2007

Primary Completion

April 1, 2010

Study Completion

December 1, 2011

Last Updated

December 31, 2015

Results First Posted

December 3, 2015

Record last verified: 2015-12

Locations

US(1)