E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects who are scheduled to undergo non-urgent PCI, or non-urgent cardiac catherization with the intent to undergo PCI. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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-urgent PCI, and as maintenance therapy after the procedure. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will include evaluation of SCH 530348 in terms of 1. incidence and tolerability of bleeding that does not meet the TIMI criteria for major or minor; 2. incidence of clinically important bleeding that occurs after discharge from the hospital; 3. inhibition of platelet aggregation induced by various appropriate agonists, including TRAP thrombin-receptor agonist peptide as an indicator of the desired pharmacodynamic effect; 4. incidence of the composite endpoint of death and major adverse cardiac events MACE; any of non-fatal myocardial infarction MI , ischemia requiring rehospitalization, or coronary revascularization with either coronary artery bypass grafting CABG or subsequent PCI in addition to the standard of care in subjects undergoing non-urgent PCI, and as maintenance therapy after the procedure as a measure of potential clinical benefit; 5. incidence of the individual components of the death/MACE composite, as well as the incidences of other |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The subject must meet all criteria listed below for entry 1. man or woman of any race/ethnicity aged 8805;55 years who has had symptoms of CAD; 2. scheduled to undergo non-urgent PCI, or non-urgent 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 2 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication acceptable methods of contraception include condoms male or female with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD intrauterine device , oral or injectable hormonal contraceptive, and surgical sterilization eg, hysterectomy or tubal ligation . |
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E.4 | Principal exclusion criteria |
Results of any tests, recordings, or procedures that are part of standard-of care preadmission testing or of other testing after admission may be used during evaluation for exclusion criteria. The subject will be excluded from entry if any of the criteria listed below are met 1. pregnancy premenopausal women should have a negative pregnancy test result confirmed before enrollment ; 2. any serious illness or any condition or situation that the investigator feels would interfere with the study evaluations or optimal participation in the study, or pose a significant hazard to the subject if investigational therapy were initiated; 3. known hypersensitivity to any component of the current investigational product; 4. participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment; 5. member of the staff personnel directly involved with this study; 6. family member of the investigational study staff. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |