Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention

Launched by MARCO VALGIMIGLI · Feb 7, 2008

Keywords

ClinConnect Summary

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 coronary stenting compared to currently recommended antiplatelet regimens (i.e. dual antiplatelet treatment for minimum 1 month after BMS or 6 months after DES implantation). As the degree of intimal hyperplasia (IH) suppression provided by the coronary stent system may be expected to influence the comparison between conventional versus prolonged dual antiplatelet treatment (DAT), patients in each gr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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 Criteria:
• • 1. 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.
• • 2. Allergy or intolerance to aspirin, or both clopidogrel and ticlopidine
• 3. 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.
• • 4. Subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
• • 5. History of clinically important, recent or ongoing alcohol abuse or other drug abuse.
• • 6. Known platelet count \<100,000/mm3 (\<100 x 109/L).
• • 7. Subjects who is unable to give informed consent and assurance for complete contact through 2 years.