Trial · NCT02091921
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
NCT02091921, Phase 1, Phase 2, Completed, University of Southern California; results first posted 2019-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study. Trials, record NCT02091921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02091921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
- NCT number
- NCT02091921
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Critical Limb Ischemia
- Interventions
- Ticagrelor
- First posted
- 2014-03-19
- Last updated
- 2019-06-19
- Results first posted
- 2019-06-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Two weeks | 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 |
| Secondary | 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. | Two weeks | 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% . |
| Secondary | Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks. | Two weeks | 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 |
| Secondary | Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. | Two weeks | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Two weeks | P2Y12 reaction units (PRU) | MEAN | |
| SECONDARY | 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. | Two weeks | Participants who demonstrated on the High Platelet Reactivity (HPR) on clopidogrel and had Appropriate Platelet Inhibition (API) on ticagrelor | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks. | Two weeks | Participants who demonstrated API on Clopidogrel and remained with API after switching to Ticagrelor | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. | Two weeks | 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 | Correlation Coefficient | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Ticagrelor | Clopidogrel Baseline | 173 | 95% Confidence Interval 149 to 196 | P2Y12 reaction units (PRU) |
| To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Ticagrelor | Clopidogrel 6+-1 hour after the baseline dose | 140 | 95% Confidence Interval 116 to 163 | P2Y12 reaction units (PRU) |
| To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Ticagrelor | Ticagrelor Baseline | 71 | 95% Confidence Interval 47 to 94 | P2Y12 reaction units (PRU) |
| To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. | Ticagrelor | Ticagrelor 6+-1 hour after baseline | 63 | 95% Confidence Interval 39 to 86 | P2Y12 reaction units (PRU) |
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. | HPR on Clopidogrel and API on Ticagrelor | 17 | Participants | ||
| Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks. | API on Clopidogrel and API on Ticagrelor | 32 | Participants | ||
| Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. | Correlation of PRU and VASP-PRI | Clopidogrel | 0.73 | Correlation Coefficient | |
| Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. | Correlation of PRU and VASP-PRI | Ticagrelor | 0.47 | Correlation Coefficient | |
| Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. | Correlation of PRU and VASP-PRI | Overall Group | 0.6 | Correlation Coefficient |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental | 53 | |
| Overall Study | COMPLETED | Experimental | 50 | |
| Overall Study | NOT COMPLETED | Experimental | 3 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin reaction | Skin and subcutaneous tissue disorders | Experimental | 1 | 53 | 1 |
| serious | Hospitalization for Pneumonia | Respiratory, thoracic and mediastinal disorders | Experimental | 1 | 53 | 1 |
| serious | Rheumatoid arthritis pericarditis | Immune system disorders | Experimental | 1 | 53 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental | 0 | 53 |
| Total, other adverse events | Experimental | 1 | 53 |
| Total, serious adverse events | Experimental | 1 | 53 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02091921
GET https://conductscience.org/api/trials/v1/NCT02091921/registered