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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marco Valgimigli
• Treatments: Albumin-Bound Paclitaxel; Aspirin; Clopidogrel; Everolimus; Paclitaxel; Purinergic P2Y Receptor Antagonists; Sirolimus; Ticlopidine

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.