Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

NCT01233167 | Unknown DMC

• 1 other identifier: SRRSH-CVD-001
• Study Type: interventional
• Target: 5,232
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.

Conditions

Coronary Artery Disease

Keywords

dual antiplatelet therapy; sirolimus drug-eluting stent; major adverse cardiac events; bleeding

Outcome Measures

Primary Outcomes (5)

• all cause mortality

  one year

• nonfatal myocardial infarction

  one year

• clinical-driven target vessel revascularization

  one year

• cardiac death

  one year

• stent thrombosis

  one year

Secondary Outcomes (6)

• death

  one year

• myocardial infarction

  one year

• any repeat revascularization

  one year

• strokes

  one year

• dialysis/hemofiltration

  one year

Study Arms (3)

clopidogrel

EXPERIMENTAL

Drug: clopidogrel

placebo

PLACEBO COMPARATOR

Drug: placebo

steply discontinued clopidogrel

EXPERIMENTAL

Drug: clopidogrel and placebo

Interventions

clopidogrel DRUG

clopidogrel 75 mg po per day for 12 months

clopidogrel

placebo DRUG

placebo 75mg po per day for 12 months

placebo

clopidogrel and placebo DRUG

clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months

steply discontinued clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of older.
• The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents).
• Angiographically confirmed major epicardial vessels (\>=2.5mm in diameter) without significant stenosis or restenosis (\>=50%).
• Geographically accessible and willing to come in for required study visits.
• Signed informed consent.

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel.
• Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months.
• EF\<35% within 12 months.
• Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases.
• Previous ACS within 12 months.
• Previous stroke or transient ischemia attack within 12 months.
• Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months.
• Current enrollment in another clinical trial.
• Suspected pregnancy.
• Big bleeding events within 12 months.
• Planned surgical procedure.
• Previous other type DES implantation or BMS implantation history.
• Extra-cardiac stent implantation history.
• Current or planned dialysis.
• The patient has a known hypersensitivity or contraindication to statins.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Hemorrhage

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

He Huang, Doctor of Medicine

CONTACT

860571-86006246; huanghell@163.com

Guo-sheng Fu, Doctor of Philosopy

CONTACT

860571-86006490; fugs64@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 3, 2010
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 20, 2011

Record last verified: 2010-10