Trial Outcomes & Findings for XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (NCT NCT01106534)
NCT ID: NCT01106534
Last Updated: 2023-11-14
Results Overview
COMPLETED
PHASE4
870 participants
12-33 months post-stent
2023-11-14
Participant Flow
Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.
Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520. Outcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379.
Participant milestones
| Measure |
Second Enrollment Phase of XIENCE V® USA
Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.
|
|---|---|
|
Overall Study
STARTED
|
2997
|
|
Overall Study
COMPLETED
|
2960
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Second Enrollment Phase of XIENCE V® USA
Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
16
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Baseline characteristics by cohort
| Measure |
Second Enrollment Phase of XIENCE V® USA
n=2997 Participants
Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.
|
|---|---|
|
Age, Continuous
|
64.27 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Age, Customized
< 65 years
|
1587 participants
n=5 Participants
|
|
Age, Customized
>= 65 to < 75 years
|
922 participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
488 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
870 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2127 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
49 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
231 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2577 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
117 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-33 months post-stentPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12-33 months post-stentPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12-33 months post-stentPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 months and 12 through 33 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 months and 12 through 33 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 through 30 months and 12 through 33 monthsPopulation: Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Second Enrollment Phase of XIENCE V® USA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60