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CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)
During Phase I (non-randomized phase) of this study, the primary objective is to assess the rate of target lesion failure in subjects implanted with the CYPHER® stent and receiving dual antiplatelet therapy for 12 months.
During Phase II (randomized phase) of this study, the primary objective is to assess safety (major and minor bleeding), MACCE, and ST rates in subjects treated with dual antiplatelet therapy for 12 or 30 months following CYPHER® stent implantation.
*Subjects treated with the CYPHER® 2.25mm stent will be followed through 60 months.
**The last 500 patients enrolled will not be eligible for randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12m DAPT Group | Placebo Comparator |
| |
| 30m DAPT Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel & Aspirin, Prasugrel & 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 thienopyridine treatment in addition to aspirin. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: the Rate of Target Lesion Failure (TLF) | Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device Success | A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | From post- procedure to hospital discharge, up to 39 days |
| Rate of Lesion Success |
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DAPT Group - Inclusion Criteria:
Phase I: Enrollment Inclusion Criteria
Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:
DAPT Group Phase II: Randomization Inclusion Criterion at 12 months
Subjects must meet the following criterion to be eligible for randomization in the study:
DAPT Group - Exclusion Criteria:
Phase I: Enrollment Exclusion Criteria
Subjects will be excluded if ANY of the following exclusion criteria apply:
DAPT Group Phase II: Randomization Exclusion Criteria at 12 months
Subjects will be excluded from randomization if any of the following criteria are met:
Non-DAPT Group
The following inclusion and exclusion criteria are for the Non-DAPT subjects. These criteria will be used to determine if the subject meets the near on-label definition
Non-DAPT Group - Inclusion Criteria:
Subjects must meet ALL of the following criteria to be enrolled in this study:
Non-DAPT Group - Exclusion criteria
And must NOT meet any of the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Simon, M.D. | University Hospitals, Case Medical Center (Cleveland) | Principal Investigator |
| David Kandzari, M.D. | Piedmont Hospital, Atlanta, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals, Case Medical Center (Cleveland) | Cleveland | Ohio | 44106 | United States |
During the Phase I of this study, enrolled subjects were treated with at least one CYPHER® stent plus thienopyridine treatment and aspirin. During Phase II, approximately 1500 eligible subjects were randomized to either placebo or thienopyridine treatment. It is estimated that the Phase II results will be available for publishing by July 31, 2014.
A total of 2509 patients were enrolled from August 28, 2009 to January 14, 2011 across 139 clinical sites in the Unites States.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled subjects were those who signed the informed consent and had met all of the inclusion and none of the exclusion criteria, and the target lesion had been successfully crossed with the intracoronary guidewire which was positioned intraluminally in the distal vessel. Enrolled subjects were also Intent to Treat (ITT).
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| ID | Title | Description |
|---|---|---|
| BG000 | CYPHER® Stent | The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Phase I: the Rate of Target Lesion Failure (TLF) | Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months. | Active subjects in the ITT population at 12-month post procedure | Posted | Number | participants | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CYPHER® Stent | The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Orlick, Associate Director | Cordis Corporation, a Johnson & Johnson company | 908-541-4347 | aorlick@its.jnj.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| 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. |
|
Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method. |
| From post- procedure to hospital discharge, up to 39 days |
| Rate of Procedure Success | Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay. | From post- procedure to hospital discharge, up to 39 days |
| Rate of Clinically-driven Target Lesion Revascularization (TVR) | Defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA. | 12 Months |
| Rate of Clinically Driven Target Vessel Revascularization (TVR) | Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA. | 12 months |
| Rate of Target Vessel Failure (TVF) | Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. | 12 Months |
| Rate of Major Adverse Cardiac Events (MACE) | MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months | 12 Months |
| Rate of Protocol Defined Stent Thrombosis (ST) | Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel. | 12 Months |
| Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST) | ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure. | 12 Months |
| Rate of Protocol Defined Major Bleeding Complications | Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined. | 12 Months |
| Rate of Cardiac Death | Include all deaths due to cardiac causes. | 12 Months |
| Rate of Non-cardiac Death | Include all deaths due to non-cardiac causes. | 12 Months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Rate of Device Success | A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | The total number of devices the Intent-to-Treat patients used in the study. | Posted | Number | Devices | From post- procedure to hospital discharge, up to 39 days | Devices | Participants |
|
|
|
|
| Secondary | Rate of Lesion Success | Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method. | The total number of lesions the Intent-to-Treat population had at the beginning of the study | Posted | Number | Lesions | From post- procedure to hospital discharge, up to 39 days | Lesions | Participants |
|
|
|
|
| Secondary | Rate of Procedure Success | Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay. | Intent-to-Treat Population | Posted | Number | participants | From post- procedure to hospital discharge, up to 39 days |
|
|
|
|
| Secondary | Rate of Clinically-driven Target Lesion Revascularization (TVR) | Defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Clinically Driven Target Vessel Revascularization (TVR) | Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up). | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Rate of Target Vessel Failure (TVF) | Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up). | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Major Adverse Cardiac Events (MACE) | MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up). | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Protocol Defined Stent Thrombosis (ST) | Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST) | ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Protocol Defined Major Bleeding Complications | Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Cardiac Death | Include all deaths due to cardiac causes. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| Secondary | Rate of Non-cardiac Death | Include all deaths due to non-cardiac causes. | ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up) | Posted | Number | participants | 12 Months |
|
|
|
|
| 34 |
| 2,509 |
| 414 |
| 2,509 |
| Non-cardiac death | General disorders | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Catheter site haematoma | General disorders | Systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coronary artery dissection | Cardiac disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |