رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT05997693 (ODIN) لـ Chronic Coronary Disease هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
One-Month DAPT in CABG Patients (ODIN) المرحلة الثالثة ٧٠٠
One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
- ODIN
- 23-06026202
- 2023-506613-22 (رقم EudraCT)
- 488058 (رقم منحة/تمويل آخر) (Canadian Institutes of Health Research (CIHR))
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةTicagrelor 90 mg + Low-Dose Aspirin | Ticagrelor 90 MG Ticagrelor 90 mg twice daily taken orally for one month Low-dose aspirin 75-150 mg once daily taken orally |
مقارن نشطLow-Dose Aspirin Alone | Low-dose aspirin 75-150 mg once daily taken orally |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to coronary revascularization
5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month | 1 year |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to BARC 3 bleeding
5. Time to coronary revascularization
6. Presence of graft failure at 12-month imaging follow-up | 1 year |
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to coronary revascularization
5. 5-year time-averaged disease-specific QOL (SAQ-7) score | 5 years |
Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to BARC 3 bleeding
5. Time to coronary revascularization
6. 5-year time-averaged disease-specific QOL (SAQ-7) score | 5 years |
- Age ≥18 years
- Elective first-time CABG with use of ≥1 saphenous vein graft;
- Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.
Any indication for dual antiplatelet therapy, including
- Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
- Recent PCI requiring continuation of dual antiplatelet therapy after CABG
Current or anticipated use of oral anticoagulation;
Paroxysmal, persistent or permanent atrial fibrillation;
Any concomitant cardiac or non-cardiac procedure;
Planned cardiac or non-cardiac surgery within one year;
Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
Inability to use the saphenous vein;
Contraindications to the use of aspirin;
Contraindications to the use of ticagrelor, including
- Known hypersensitivity to ticagrelor
- Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
- History of intracranial hemorrhage
- Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
Inability to undergo coronary computed tomographic angiography (CCTA);
Participating in another investigational device or drug study;
Women of childbearing potential
Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.
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