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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,509
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.
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.
University Hospitals, Case Medical Center (Cleveland)
Cleveland, Ohio, United States
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.
Time frame: 12 months
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.
Time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Lesion Success
Lesion success is defined as the attainment of \< 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
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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.
Time frame: 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.
Time frame: 12 Months
Rate of Major Adverse Cardiac Events (MACE)
MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months
Rate of Cardiac Death
Include all deaths due to cardiac causes.
Time frame: 12 Months
Rate of Non-cardiac Death
Include all deaths due to non-cardiac causes.
Time frame: 12 Months