Effectiveness of Prasugrel versus Clopidogrel in Subjects with High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention with Implantation of Drug-Eluting Stent - TACW
- Conditions
- Reduction of composite cardio-vascular end-point in patients who have successfully undergone elective percutaneous coronary intervention with placement of at least one drug-eluting stent.
- Registration Number
- EUCTR2008-004997-41-DE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3250
[1] Subjects with coronary artery disease and clinical indication for PCI
with implantation of at least one DES, and in whom PCI of all treated
lesions is successful (diameter stenosis <30% with TIMI 3 flow in all
treated vessels) without major complications (definition s. excl. crit.)
One or more bare metal stents (BMS) may be implanted, and other
lesions may be treated without stenting, as long as at least one DES is
implanted. However, the procedure must be successful and
uncomplicated for all lesions (DES + BMS + non stent).
[2] Standard of care clopidogrel 600-mg LD must have been given
between 24 hours before, and the time of, PCI. A non-study-related
standard of care clopidogrel 75-mg MD must have been administered
in the morning of the day following PCI. (Administration of an
additional non-study-related standard of care clopidogrel 75-mg MD in
the evening of PCI should be avoided but is permitted if this is
standard of care at the institution).
[3] VerifyNow™ PRU >208, measured 2 to 7 hours after a clopidogrel
MD received the morning after successful PCI.
[4] Aspirin use prior to PCI: A non-study-related dose of at least 250-mg
(IV or oral) within 24 hours prior to PCI, and the time of PCI.
[5] Only stents that are CE marked for approval may be used in this study.
[6] PCI must have been performed with unfractionated or low molecular
weight heparin, or bivalirudin as the procedural antithrombin.
[7] Are of a legal age (and at least 18 years of age) and competent mental
condition to provide written informed consent before entering the
study. Informed consent must be signed by the study participant or
authorized representative, according to local rules and regulations.
[8] For women of child-bearing potential only (that is, women who are not
surgically or chemically sterilized and who are between menarche and
1 year postmenopause), test negative for pregnancy (based on a urine
or serum pregnancy test to be performed before randomization) and
agree to use a reliable method of birth control (Pearl Index < 1%)
during the study. A highly effective method of birth control is defined
as those which result in a low failure rate (i.e., =1% per year)
when used consistently and correctly such as implants, injectables,
combined oral contraceptives, some IUDs, sexual abstinence or
vasectomised partner.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[9] Subjects with non-ST-segment elevation myocardial infarction
(NSTEMI) within 14 days prior to randomization. NSTEMI is defined
as a history of chest discomfort or ischemic symptoms of =10 minutes
duration at rest, with no evidence of persistent ST-segment elevation
and with troponin T or I greater than the upper limit of normal (ULN).
[10] Subjects with ST-segment elevation myocardial infarction (STEMI)
within 14 days prior to randomization. STEMI is defined as a history
of chest discomfort or ischemic symptoms of >20 minutes duration at
rest with one of the following present on at least one ECG prior to
PCI:
(a) ST-segment elevation =1 mm in two or more contiguous ECG
leads.
(b) New or presumably new left bundle branch block (LBBB).
(c) ST-segment depression =1 mm in two anterior precordial leads
(V1 through V4) with clinical history and evidence suggestive of
true posterior infarction.
[11] Subjects with known major complications after PCI and prior to
randomization defined as:
(a) ST-segment elevation myocardial infarction (STEMI).
(b) Stent thrombosis.
(c) Large non-ST-segment elevation myocardial infarction (NSTEMI)
defined as an increase in CK >5 x ULN with concomitant rise in
CK-MB.
(d) Major bleeding at the vascular access site (drop in Hgb of =5g/dL
or requiring transfusion).
(e) False aneurysma.
[12] Have cardiogenic shock at the time of randomization (systolic blood
pressure <90 mm Hg associated with clinical evidence of end-organ
hypoperfusion, or subjects requiring vasopressors to maintain systolic
blood pressure over 90 mm Hg and associated with clinical evidence
of end-organ hypoperfusion).
[13] Have refractory ventricular arrhythmias.
[14] Have New York Heart Association (NYHA) Class IV congestive heart
failure (CHF; see Attachment TACW.3).
[15] Have received fibrin-specific fibrinolytic therapy <24 hours prior to
randomization.
[16] Have received nonfibrin-specific fibrinolytic therapy <48 hours prior
to randomization.
[17] Have active internal bleeding or history of major bleeding diathesis.
[18] Have clinical findings, in the judgment of the investigator, associated
with an increased risk of bleeding.
[19] Non-cardiac surgery within 4 weeks prior to PCI.
[20] Have any of the following:
(a) Prior history of hemorrhagic or ischemic stroke, a transient
ischemic attack, or sub-arachnoid hemorrhage.
(b) Intracranial neoplasm, arteriovenous malformation, or aneurysm.
[21] Have an International Normalized Ratio (INR) >1.5 at the time of
evaluation.
[22] Have a platelet count of <100,000/mm3 at the time of screening.
[23] Have known anemia (Hgb <10 gm/dL) at the time of screening.
[24] Have a body weight <60 kg.
[25] Have an age of >80 years.
[26] Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24
hours before or during PCI or abciximab within 10 days before or
during PCI.
[27] Are receiving or will receive oral anticoagulation or other antiplatelet
therapy besides aspirin that cannot be safely discontinued for the
duration of the study.
[28] Are receiving daily treatment with nonsteroidal anti-inflammatory
drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot
be discontinued or are anticipated to require >2 weeks of daily
treatment with NSAID or COX2 inhibitors during the study.
[29] Are employed by Eli Lilly and Company, Ube Industries Limited, or
Daiichi Sankyo Company, Ltd.
[30] Investigator site, ARO or CRO personnel directly affiliated with this
study and/or their immediate families.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method