Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02091921
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2014-03-17
Brief Title:
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STT-CLIPS
Brief Summary:
Critical Limb Ischemia CLI is defined as limb pain that occurs at rest or impending limb loss that is caused by severe compromise of blood flow to the affected extremity CLI is a major cause of death and disability secondary to myocardial infarction stroke and amputation The mortality in patients with CLI approaches 13-25 and 50 at one and five years respectively High on-treatment platelet reactivity HPR in patients treated with aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events after percutaneous coronary interventions and coronary syndromes Preliminary studies suggest that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and clopidogrel is as high a 785 In patients with coronary artery disease ticagrelor overcomes non-responsiveness to clopidogrel However the antiplatelet effect of ticagrelor in patients with critical limb ischemia is unknown
Detailed Description:
Study Aim This pilot study aims to investigate platelet function after switching from clopidogrel to ticagrelor in patients with critical limb ischemia
Fifty patients with diagnosis of CLI Rutherford class IV-VI treated with clopidogrel 75 mg and aspirin 81 mg daily will be tested for inhibition of platelet aggregation using the VerifyNow P2Y12 and VASP assays before and 61 hours after their daily clopidogrel dose All patients will then be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and Vasodilator-Stimulated Phosphoprotein VASP platelet reactivity assays repeated samples will be collected before and 61 hours after the last ticagrelor dose For exploratory analysis patients will be divided in two groups based on the P2Y12 reaction units PRU Group 1 High on treatment platelet reactivity on clopidogrel HPR defined as P2Y12 reaction units PRU 208 and Group 2 Appropriate platelet inhibition on clopidogrel API defined as P2Y12 reaction units PRU 208 If subjects are withdrawn from the study prior to completion due to the high co-morbidity rate of this population additional subjects will be enrolled to reach a total of 50 completed subjects for data analysis
Fifty patients with diagnosis of CLI Rutherford class IV-VI treated with clopidogrel 75 mg and aspirin 81 mg daily will be tested for inhibition of platelet aggregation using the VerifyNow P2Y12 and VASP assays before and 61 hours after their daily clopidogrel dose All patients will then be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and Vasodilator-Stimulated Phosphoprotein VASP platelet reactivity assays repeated samples will be collected before and 61 hours after the last ticagrelor dose For exploratory analysis patients will be divided in two groups based on the P2Y12 reaction units PRU Group 1 High on treatment platelet reactivity on clopidogrel HPR defined as P2Y12 reaction units PRU 208 and Group 2 Appropriate platelet inhibition on clopidogrel API defined as P2Y12 reaction units PRU 208 If subjects are withdrawn from the study prior to completion due to the high co-morbidity rate of this population additional subjects will be enrolled to reach a total of 50 completed subjects for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS-13-00562 | OTHER | IRB | None |