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Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study (STT-CLIPS)

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ClinicalTrials.gov Identifier: NCT02091921
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Leonardo Clavijo, University of Southern California

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Critical Limb Ischemia
Intervention Drug: Ticagrelor
Enrollment 53
Recruitment Details Patients with diagnosis of CLI (Rutherford class IV, V and VI) on continuous dual antiplatelet therapy with clopidogrel 75 mg and aspirin 81 mg daily for at least 14+2 days
Pre-assignment Details

A total of 53 patients consented and enrolled the study. 3 patients were excluded from the study and did not complete the study; one developed a skin reaction after the first IP dose; the other two due to events unrelated to the study (Pneumonia and Rheumatoid arthritis pericarditis).

50 Patients completed the study.

Arm/Group Title Experimental
Hide Arm/Group Description

All subjects will receive Ticagrelor.

Ticagrelor: All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.

Period Title: Overall Study
Started 53
Completed 50
Not Completed 3
Reason Not Completed
Adverse Event             3
Arm/Group Title Experimental
Hide Arm/Group Description

All subjects will receive Ticagrelor.

Ticagrelor: All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.

Overall Number of Baseline Participants 50
Overall Number of Units Analyzed
Type of Units Analyzed: Blood samples
50
Hide Baseline Analysis Population Description
The study analysis was based on the 50 patients who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
65.3  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
23
  46.0%
Male
27
  54.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
 100.0%
1.Primary Outcome
Title To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI.
Hide Description Patients platelet inhibition was analyzed based on the P2Y12 reaction units (PRU) as high on treatment platelet reactivity (HPR), defined as P2Y12 reaction units (PRU) ≥208 and appropriate platelet inhibition on (API), defined as P2Y12 reaction units (PRU) <208
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor
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All patients were switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks
Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: P2Y12 reaction units (PRU)
Clopidogrel Baseline
173
(149 to 196)
Clopidogrel 6+-1 hour after the baseline dose
140
(116 to 163)
Ticagrelor Baseline
71
(47 to 94)
Ticagrelor 6+-1 hour after baseline
63
(39 to 86)
2.Secondary Outcome
Title Establish the Number of Participants in the High On-treatment Platelet Reactivity (HPR) on Clopidogrel Group Who Demonstrated Appropriate Platelet Inhibition (API) After Switching to Ticagrelor for Two Weeks.
Hide Description This measure was obtained by the number of participants who demonstrated high on treatment platelet reactivity (PRU > / = 208) on Clopidogrel, and the number of participants who also resulted in the Appropriate Platelet Inhibition (PRU < 208) after switching to Ticagrelor for two weeks of uninterrupted therapy x 100% .
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who demonstrated on the High Platelet Reactivity (HPR) on clopidogrel and had Appropriate Platelet Inhibition (API) on ticagrelor
Arm/Group Title HPR on Clopidogrel and API on Ticagrelor
Hide Arm/Group Description:
Participants who demonstrated HPR on clopidogrel
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
17
  94.4%
3.Secondary Outcome
Title Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks.
Hide Description The measure was obtained from the number of participants in the Appropriate Platelet Inhibition (PRU < 208) on Clopidogrel and who remained with Appropriate Platelet Inhibition after switching to Ticagrelor for two weeks of uninterrupted therapy x 100
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who demonstrated API on Clopidogrel and remained with API after switching to Ticagrelor
Arm/Group Title API on Clopidogrel and API on Ticagrelor
Hide Arm/Group Description:
Participants with Appropriate Platelet Inhibition (API) on Clopidogrel.
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
32
 100.0%
4.Secondary Outcome
Title Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy.
Hide Description Correlation between the P2Y12 Reaction Units (PRU) and the Vasodilator-Stimulated Phosphoprotein Assay-Platelet Reactivity Index (VASP-PRI) used to test the inhibition of platelet aggregation after two weeks of uninterrupted therapy with Clopidogrel versus Ticagrelor in CLI participants
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were on Clopidogrel 75mg daily for at least two weeks and then switched to Ticagrelor 90mg twice daily for two weeks of uninterrupted therapy
Arm/Group Title Correlation of PRU and VASP-PRI
Hide Arm/Group Description:
Participants who were switched from clopidogrel to ticagrelor
Overall Number of Participants Analyzed 50
Overall Number of Units Analyzed
Type of Units Analyzed: Correlation Coefficient
200
Measure Type: Number
Unit of Measure: Correlation Coefficient
Clopidogrel 0.73
Ticagrelor 0.47
Overall Group 0.6
Time Frame Two weeks
Adverse Event Reporting Description The adverse event and/or serious adverse event, used to collect adverse event information, adheres to the clinicaltrials.gov definition
 
Arm/Group Title Experimental
Hide Arm/Group Description All participants will switch from clopidogrel to ticagrelor for two weeks
All-Cause Mortality
Experimental
Affected / at Risk (%)
Total   0/53 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental
Affected / at Risk (%) # Events
Total   1/53 (1.89%)    
Immune system disorders   
Rheumatoid arthritis pericarditis  [1]  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
Hospitalization for Pneumonia  [1]  1/53 (1.89%)  1
Indicates events were collected by systematic assessment
[1]
considered unrelated to the study intervention
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental
Affected / at Risk (%) # Events
Total   1/53 (1.89%)    
Skin and subcutaneous tissue disorders   
Skin reaction   1/53 (1.89%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Leonardo Clavijo, MD
Organization: University of Southern California
Phone: 3234426130
Responsible Party: Leonardo Clavijo, University of Southern California
ClinicalTrials.gov Identifier: NCT02091921     History of Changes
Other Study ID Numbers: D5130L00068//ISSBRIL0198
HS-13-00562 ( Other Identifier: IRB )
First Submitted: March 17, 2014
First Posted: March 19, 2014
Results First Submitted: March 31, 2017
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019