Subjects with symptoms of Coronary Heart Disease
Conditions
Interventions
Product Code: SCH 530348
Pharmaceutical Form: Tablet
CAS Number: 705260-08-8
Current Sponsor code: SCH 530348
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
P
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all the following: 1. man or woman of any race/ethnicity greater than or equal to 45 years who has had symptoms of CAD; 2. scheduled to undergo non-emergent PCI, or non-emergent cardiac catheterization with the intent to undergo PCI; 3. no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to initiation of intervention if the subject were not a participant in the current trial, and no anticipation of use during this trial; 4. willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules; and 5. women of child-bearing potential (all postmenarchal women who are =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject will be excluded if one of the following are met: 1. pregnancy (premenopausal women should have a negative pregnancy test result confirmed before enrollment); 2. ongoing chest pain (or anginal equivalent) leading to urgent referral for PCI, or ongoing chest pain (or anginal equivalent) at the time of study enrollment; 3. history of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment; 4. stroke or transient ischemic attack (TIA) of any cause or origin within 30 days before enrollment, or history of a hemorrhagic stroke at any time; 5. severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy; 6. known platelet count 2.0 mg/dL [>176.8 micromol/L]), dysproteinemia, nephrotic syndrome, or other renal disease (24-hour urinary protein greater than or equal to 3+ or greater than or equal to 1 g); 9. active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) activity more than three times greater than the upper limit of the laboratory reference range; 10. major surgery within 6 weeks before enrollment; 11. concurrent treatment with a Factor Xa inhibitor; 12. anticipated subsequent staged multivessel PCI procedure within a period of 30 days after enrollment; 13. concurrent or anticipated treatment with warfarin after enrollment; 14. treatment with any parenteral GP IIb/IIIa inhibitor within the previous 30 days before enrollment, or concurrent treatment with any other antiplatelet agent other than aspirin and clopidogrel, or with any other PAR 1 inhibitor; 15. anticipated intracoronary brachytherapy; 16. serious illness/condition that the investigator feels would interfere with the study evaluations or participation in the studyor pose a hazard to the subject; 17. known hypersensitivity to any component of the IMP; 18. participation in a study of experimental therapy or use of any investigational drug within 30 days of enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety of SCH 530348 with respect to the incidence of major and minor bleeding events, as assessed by the TIMI (Thrombolysis in Myocardial Infarction cooperative group) system of classification, in addition to the standard of care in subjects undergoing non-emergent PCI, and as maintenance therapy after the procedure.;Secondary Objective: 1. incidence/tolerability of bleeding not meeting the TIMI major or minor criteria; 2. incidence of "clinically important" bleeding occurring after discharge; 3. inhibition of platelet aggregation induced by various agonists as an indicator of the desired pharmacodynamic effect; 4. incidence of the composite endpoint of death and major adverse cardiac events (MACE: non-fatal MI, ischemia requiring rehospitalization, or coronary revascularization with CABG or PCI) in addition to standard of care and as maintenance therapy as a measure of clinical benefit; 5. incidence of the individual components of the death/MACE composite, as well as other composites such as (a) cardiovascular death and nonfatal MI, (b) cardiovascular death and stroke, and (c) cardiovascular death, nonfatal MI, and stroke as measures of clinical benefit and 6. effect on expression of markers of inflammation and of platelet release and activation (ie, hs-CRP, CD40 ligand [CD40L], and membrane-bound P-selectin). ;Primary end point(s): The incidence of TIMI major plus minor bleeding in the primary evaluable cohort (those undergoing PCI) through the end of treatment. TIMI Major bleeding will be defined as (1) intracranial hemorrhage or (2) clinically significant overt signs of bleeding associated with a decrease in hemoglobin concentration of >5 g/dL (or hematocrit >15%). TIMI Minor bleeding will be defined as clinically overt signs of bleeding associated with a decrease in hemoglobin concentration of 3 to less than or equal to 5 g/dL (hematocrit 9% to less than or equal to 15%) that does not otherwise meet cr | — |
Countries
Germany, Italy, Sweden
Outcome results
None listed