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Trial record 24 of 402 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)

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ClinicalTrials.gov Identifier: NCT02094755
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Leonardo Clavijo, University of Southern California

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Critical Limb Ischemia
Intervention Other: Blood draw only
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Cohort
Hide Arm/Group Description

Single cohort will receive Blood draw only.

Blood draw only: Blood draw only

Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Single Cohort
Hide Arm/Group Description

Single cohort will receive Blood draw only.

Blood draw only: Blood draw only

Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
67.2  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
50
  50.0%
Male
50
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
 100.0%
1.Primary Outcome
Title Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel.
Hide Description Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purinergic receptor P2Y12 (VN-P2Y12) assays.
Time Frame Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel
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Hide Analysis Population Description

High on-treatment platelet reactivity on clopidigrel (HPRC) was defined as VerifyNow®P2Y12 reactive units (PRU) >208 and VASP-platelet reactivity index (VASP-PRI) >50%.

Thromboxane A2 (TXA2) inhibition was measured with the VerifyNow®aspirin test and High on-treatment reactivity on aspirin (HPRA) was defined as aspirin reaction units (ARU) >550.

Arm/Group Title Single Cohort
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Patients were included who had a diagnosis of CLI and who received uninterrupted treatment with ASA and/or clopidogrel for ≥1 week prior to platelet inhibition testing.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
HPR on Clopidogrel
18
  18.0%
HPR on Aspirin
17
  17.0%
HPR on Both
8
   8.0%
API on Both
57
  57.0%
Time Frame Critical limb ischemia patients with clinical indication of aspirin and clopidogrel dual antiplatelet therapy with for at least 1 week as standard of care, were monitored for adverse events for the length of study participation which was 1 day from study enrollment to the last study intervention.
Adverse Event Reporting Description In adherence to the clinical trials.gov adverse event and serious adverse event definitions
 
Arm/Group Title Single Cohort
Hide Arm/Group Description

Single cohort will receive Blood draw only.

Blood draw only: Blood draw only

All-Cause Mortality
Single Cohort
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Cohort
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Cohort
Affected / at Risk (%)
Total   0/100 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Leonardo Clavijo
Organization: University of Southern California
Phone: 3234426130
Responsible Party: Leonardo Clavijo, University of Southern California
ClinicalTrials.gov Identifier: NCT02094755     History of Changes
Other Study ID Numbers: D5130L00047/ISSBRIL0152
First Submitted: March 19, 2014
First Posted: March 24, 2014
Results First Submitted: March 31, 2017
Results First Posted: June 28, 2019
Last Update Posted: June 28, 2019