Status:
COMPLETED
Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention
Lead Sponsor:
Marco Valgimigli
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to ...
Detailed Description
This is a randomized, multi-center, open-label, study to evaluate the efficacy and safety profile of prolonged dual antiplatelet treatment (i.e. up to 2-year) with aspirin and clopidogrel after corona...
Eligibility Criteria
Inclusion
- Males or females ≥ 18 years of age with coronary artery disease with low, intermediate or high-risk coronary anatomy, which is considered suitable for PCI with stent placement.
- Subjects who have provided written informed consent prior to initiation of any study-related procedures, prior to receiving any pre-procedural sedation and who agree to comply with all protocol-specified procedures.
Exclusion
- Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
- Allergy or intolerance to aspirin, or both clopidogrel and ticlopidine
- Subjects with a contraindication to anticoagulation and/or increased bleeding risk:
- Past or present bleeding disorder including a history of the following within 1 month prior to randomization: clinically relevant gastrointestinal bleeding, gross (visible) hematuria,
- Planned major surgery including CABG after or within 1 month prior to randomization.
- Any subject with a known coagulopathy, platelet disorder, or history of thrombocytopenia.
- Subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
- History of clinically important, recent or ongoing alcohol abuse or other drug abuse.
- Known platelet count \<100,000/mm3 (\<100 x 109/L).
- Subjects who is unable to give informed consent and assurance for complete contact through 2 years.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
1700 Patients enrolled
Trial Details
Trial ID
NCT00611286
Start Date
December 1 2006
End Date
October 1 2012
Last Update
October 10 2012
Active Locations (1)
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1
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Emilia-Romagna, Italy, 44100