XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort | NCT01106534

NCT01106534

Status Module

Name	Class
Baim Institute for Clinical Research	OTHER
Bristol-Myers Squibb	INDUSTRY
Eli Lilly and Company	INDUSTRY
Daiichi Sankyo

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12 month DAPT arm	Placebo Comparator	placebo + aspirin	Drug: placebo + aspirin Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
30 month DAPT arm	Active Comparator	clopidogrel + aspirin OR prasugrel + aspirin	Drug: clopidogrel + aspirin OR prasugrel + aspirin Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo + aspirin	Drug	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.

Measure	Description	Time Frame
Incidence of Composite of All Death, MI and Stroke (Defined as MACE)		12-33 months post-stent
Incidence of ARC Definite or Probable ST		12-33 months post-stent
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)		12-33 months post-stent

Measure	Description	Time Frame
MACE for ITT Population		12 through 30 months
ST for ITT Population		12 through 30 months
Major Bleeding for ITT Population

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are enrolled into the XIENCE V USA Study Phase I
The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

The inability to obtain an informed consent is an exclusion criterion.

Patients must meet the following criteria to be eligible for randomization in the study:

Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
Patient completes 1 year visit within ± 30 days window.

Patients will be excluded from randomization if any of the following criteria are met:

Pregnant women.
Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
PCI or cardiac surgery between 6 weeks post index procedure and randomization.
Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
Current medical condition with a life expectancy of less than 3 years.
Patients on warfarin or similar anticoagulant therapy.

Name	Affiliation	Role
James Hermiller, MD	Heart Center of Indianapolis	Principal Investigator
Mitch Krucoff, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Heart Clinic, PC		Birmingham	Alabama	35235	United States
Thomas Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.27± 10.39

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG0001587

>= 65 to < 75 years

Title	Measurements
	BG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000870
Male	BG0002127

Race/Ethnicity, Customized

Patient may be counted in more than one category

Number

participants

Title

Denominators

Categories

American Indian or Alaskan Native

Title	Measurements
	BG00023

Asian

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Composite of All Death, MI and Stroke (Defined as MACE)

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.

Posted

12-33 months post-stent

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Units	Counts
Participants	OG0000 OG0010

Primary

Incidence of ARC Definite or Probable ST

Posted

12-33 months post-stent

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Primary

Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)

Posted

12-33 months post-stent

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

MACE for ITT Population

Posted

12 through 30 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

ST for ITT Population

Posted

12 through 30 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

Major Bleeding for ITT Population

Posted

12 through 30 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

MACE for Treatment Population

Posted

12 through 30 months and 12 through 33 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

ST for Treatment Population

Posted

12 through 30 months and 12 through 33 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

Secondary

Major Bleeding for Treatment Population

Posted

12 through 30 months and 12 through 33 months

ID	Title	Description
OG000	12 Month DAPT Arm	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.
OG001	30 Month DAPT Arm	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.

ID	Term
D014652	Vascular Diseases
D017202	Myocardial Ischemia
D023921	Coronary Stenosis
D003327	Coronary Disease
D003324	Coronary Artery Disease
D023903	Coronary Restenosis

ID	Term
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Term
D001241	Aspirin
D000077144	Clopidogrel
D000068799	Prasugrel Hydrochloride

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D010879	Piperazines