XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)

• ClinicalTrials.gov Identifier: NCT01106534
• Recruitment Status: Completed
• First Posted: April 20, 2010
• Results First Posted: June 28, 2016
• Last Update Posted: June 28, 2016
• Sponsor: Abbott Medical Devices
• Collaborators: Baim Institute for Clinical Research; Bristol-Myers Squibb; Eli Lilly and Company; Daiichi Sankyo, Inc.
• Information provided by (Responsible Party): Abbott Medical Devices

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Chronic Total Occlusion of Coronary Artery; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
• Interventions: Drug: placebo + aspirin; Drug: clopidogrel + aspirin OR prasugrel + aspirin; Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
• Enrollment: 870

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Second Enrollment Phase of XIENCE V® USA
Arm/Group Description	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.
Period Title: Overall Study
Started	2997
Completed	2960
Not Completed	37
Reason Not Completed
Withdrawal by Subject	18
Lost to Follow-up	2
Death	16
Physician Decision	1

Baseline Characteristics

Arm/Group Title		Second Enrollment Phase of XIENCE V® USA
Arm/Group Description		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 Number of Baseline Participants		2997
Baseline Analysis Population Description		Baseline characteristics are provided for 2997 patients recruited in the second enrollment phase.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	2997 participants
		64.27 (10.39)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2997 participants
< 65 years		1587
>= 65 to < 75 years		922
>= 75 years		488
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2997 participants
	Female	870 29.0%
	Male	2127 71.0%
Race/Ethnicity, Customized [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	2997 participants
American Indian or Alaskan Native		23
Asian		49
Black or African Heritage		231
Native Hawaiian or Pacific Islander		7
White		2577
Hispanic or Latino		117
Other		15
		[1] Measure Description: Patient may be counted in more than one category

Outcome Measures

1. Primary Outcome

Title	Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
Description	[Not Specified]
Time Frame	12-33 months post-stent

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Primary Outcome

Title	Incidence of ARC Definite or Probable ST
Description	[Not Specified]
Time Frame	12-33 months post-stent

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Primary Outcome

Title	Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
Description	[Not Specified]
Time Frame	12-33 months post-stent

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	MACE for ITT Population
Description	[Not Specified]
Time Frame	12 through 30 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	ST for ITT Population
Description	[Not Specified]
Time Frame	12 through 30 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Major Bleeding for ITT Population
Description	[Not Specified]
Time Frame	12 through 30 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	MACE for Treatment Population
Description	[Not Specified]
Time Frame	12 through 30 months and 12 through 33 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	ST for Treatment Population
Description	[Not Specified]
Time Frame	12 through 30 months and 12 through 33 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Major Bleeding for Treatment Population
Description	[Not Specified]
Time Frame	12 through 30 months and 12 through 33 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	12 Month DAPT Arm	30 Month DAPT Arm
Arm/Group Description:	placebo + aspirin placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.	clopidogrel + aspirin OR prasugrel + aspirin clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	Adverse events were not be reported here as the participants enrolled in this 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.
Arm/Group Title	Second Enrollment Phase of XIENCE V® USA
Arm/Group Description	The participants enrolled in this 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.
All-Cause Mortality
	Second Enrollment Phase of XIENCE V® USA
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Second Enrollment Phase of XIENCE V® USA
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Second Enrollment Phase of XIENCE V® USA
	Affected / at Risk (%)
Total	0/0

Limitations and Caveats

The participants enrolled in this study will be followed by Abbott Vacular 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 outcomes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: David R Rutledge
• Organization: Abbott Vascular
• Phone: (408) 845-3820
• EMail: david.rutledge@av.abbott.com

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01106534
• Other Study ID Numbers: 06-374C
• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Results First Submitted: July 31, 2015
• Results First Posted: June 28, 2016
• Last Update Posted: June 28, 2016