E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug eluting stent (DES) or bara metal stent (BMS) placement for the treatment of coronary artery lesions. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055218 |
E.1.2 | Term | Ischemic heart disease |
|
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 objectives of this study are to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival free from ARC definite or probable stent thrombosis (ST) in subjects treated with drug eluting stents (DES) and extended dual antiplatelet therapy. All of the primary analyses will be performed on the primary analysis population (randomized DES subjects followed through 33 months post-procedure, including the 3 month rebound observational period).
|
|
E.2.2 | Secondary objectives of the trial |
The main secondary study hypotheses are:
DAPT subjects treated with drug-eluting stents who are free from myocardial infarction, repeat coronary revascularization, stroke, stent thrombosis, or bleeding in the first 12 months after stenting and DAPT, will have a rate of death, myocardial infarction or stroke that is non-inferior compared with the rate of propensity score matched subjects treated with bare-metal stents over the 12- 33 month post-stenting period.
DAPT subjects treated with drug-eluting stents who are free from myocardial infarction, repeat coronary revascularization, stroke, stent thrombosis, or bleeding in the first 12 months after stenting and DAPT, will have a rate of ARC definite/probable stent thrombosis (ST) that is non-inferior compared with the rate of propensity score matched subjects treated with bare-metal stents over the 12-33 month post-stenting period. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Enrollment inclusion criteria:
Subject must meet all of the following criteria to be eligible for treatment in the study: 1. Subject is > 18 years of age. 2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours). 3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation. 4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the “Patient Informed Consent Form”. The informed consent will be valid for the duration of the trial or until the subject withdraws.
Randomisation inclusion criteria:
Subject is “12 Month Clear”. Defined as subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding –“severe” or “moderate” by GUSTO classification, and ST 12 months after stent implantation and who are compliant with 12 months of DAPT following stent implantation. |
|
E.4 | Principal exclusion criteria |
Enrollment exclusion criteria:
1. Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm. 2. Pregnant women. 3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment. 4. Current medical condition with a life expectancy of less than 3 years. 5. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT study devices. The subject may only be enrolled in the DAPT Study once. 6. Subjects on warfarin or similar anticoagulant therapy. 7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted. 8. Subjects unable to give informed consent. 9. Subject treated with both DES and BMS during the index procedure.
Randomisation exclusion criteria:
1. Pregnant women. 2. Subject switched thienopyridine type or dose within 6 months prior to randomization. NOTE: thienopyridine switching during the open label portion of this study is discouraged. 3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization. 4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization. 5. Current medical condition with a life expectancy of less than 3 years. 6. Subjects on warfarin or similar anticoagulant therapy. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Co-Primary Endpoints:
Incidence of composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) 12-33 months post-stent. Incidence of ARC definite or probable stent thrombosis (ST) 12-33 months poststent.
Primary Safety Endpoint:
Major bleeding (GUSTO classification, severe and moderate bleeding combined) 12-33 months post-stent |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
The first 12 months are open, then it is a double blind |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 69 |
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 |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 15 |