Akut Koroner Sendromlu Hastalarda Prasugrel ile Clopidogrel Karşılaştırması

Sade dilde özet

Bu çalışma, akut koroner sendrom (acute coronary syndrome) yaşayan hastalarda Prasugrel ve Clopidogrel ilaçlarını (Aspirin ile birlikte) karşılaştırmıştır. Çalışmaya, son 10 gün içinde kararsız anjina/ST yükselmesiz miyokard enfarktüsü (unstable angina/non-ST-elevation myocardial infarction) geçirmiş ve yüksek risk özellikleri taşıyan hastalar katılabilmiştir. Eli Lilly and Company tarafından yürütülen çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Eli Lilly and Company

Müdahale

Clopidogrel, Prasugrel, Commercially-available Aspirin

Başlangıç

01.06.2008

Tahmini bitiş

01.04.2012

Ülkeler

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom

İlgili genler

Merkezler

• Birmingham, United States
• Huntsville, United States
• Glendale, United States
• Tucson, United States
• Fort Smith, United States
• Anaheim, United States
• Banning, United States
• Bellflower, United States
• Healdsburg, United States
• Lancaster, United States
• Long Beach, United States
• Los Angeles, United States
• Mather, United States
• Newport Beach, United States
• Palo Alto, United States
• Sacramento, United States
• San Diego, United States
• Sylmar, United States
• Yuba City, United States
• Colorado Springs, United States
• Denver, United States
• Loveland, United States
• Wheat Ridge, United States
• Washington D.C., United States
• Atlantis, United States
• Aventura, United States
• Boynton Beach, United States
• Brandon, United States
• Deerfield Beach, United States
• Hudson, United States
• Lakeland, United States
• Melbourne, United States
• Miami, United States
• Orlando, United States
• Ormond Beach, United States
• Panama City, United States
• Pensacola, United States
• Port Charlotte, United States
• Sarasota, United States
• Tallahassee, United States

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Key Inclusion Criteria:

* Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
* Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
* Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key Exclusion Criteria:

* Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
* Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
* Previous or planned PCI or CABG as treatment for the index event
* PCI/CABG within previous 30 days
* ST-segment elevation myocardial infarction (STEMI) as the index event
* Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
* History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
* History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
* Hemodialysis or peritoneal dialysis