Additional Benefit of Cilostazol to Dual Antiplatelet Therapy After Biolimus-eluting Stent Implantation

NCT01192724 | Completed Phase 4 DMC

• 1 other identifier: ABCD
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease after 2nd generation DES implantation, especially in biodegradable polymer stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject with long or multivessel coronary artery disease after biolimus-eluting stent implantation.

Conditions

Coronary Artery Disease

Keywords

Antiplatelet; Coronary artery diseae; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Device-oriented composite

  Device-oriented composite was defined as a composite of cardiac death, MI (not clearly attributable to a non-target vessel), and clinically indicated target lesion revascularization (TLR).

  One year

Secondary Outcomes (4)

• Patient-oriented composite

  One year

• Each component of device- and patient-oriented composite

  One year

• Academic Research Consortium (ARC) defined stent thrombosis

  One year

• Safety assessments

  One year

Study Arms (2)

Triple antiplatelet therapy (TAPT) group

ACTIVE COMPARATOR

3-month use of cilostazol in addition to dual antiplatelet agent

Drug: Cilostazol; Drug: Aspirin; Drug: Clopidogrel

Dual antiplatelet therapy (DAPT) group

ACTIVE COMPARATOR

Aspirin and clopidogrel (dual antiplatelet therapy, DAPT) for 1 year

Drug: Aspirin; Drug: Clopidogrel

Interventions

Cilostazol DRUG

100 mg BID, for 3 months

Also known as: pletaal

Triple antiplatelet therapy (TAPT) group

Aspirin DRUG

Aspirin 100 mg QD, for 1 year

Also known as: Aspirin protect, Astrix, Baby rhonal

Dual antiplatelet therapy (DAPT) group; Triple antiplatelet therapy (TAPT) group

Clopidogrel DRUG

Clopidogrel 75 mg QD, for 1 year

Also known as: Plavix, Plavitor, Platless

Dual antiplatelet therapy (DAPT) group; Triple antiplatelet therapy (TAPT) group

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.
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the BioMatrix® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have significant coronary artery stenosis (\>70% by visual estimate).
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, silent ischemia, positive functional study or a reversible changes in the ECG consistent with ischemia).
• Target lesion(s) located in a native coronary artery with visually estimated diameter of ≥ 2.0 and ≤ 4.24 mm
• Target lesion(s) amenable for PCI
• Lesion(s) must have at least 1 of these 2 angiographic features to be eligible
• Lesion(s) need(s) stent length ≥ 28mm (multiple stents whether are overlapped or not are allowed. No limitation of stent length)
• Multivessel coronary artery disease that need ≥2 stents regardless of stent length
• Significant (\>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter)
• Lesion(s) of chronic total occlusion or bifurcation which need ≥ 2 stents can be eligible

You may not qualify if:

• The subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, biolimus A9, stainless steel, cobalt chromium, contrast media\*. (\*Subjects with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
• Systemic (intravenous) biolimus A9 use within 12 months.
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
• Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Subjects who have received DES implantation in the any coronary artery prior to enrollment
• Creatinine level \> 3.0mg/dL or dependence on dialysis.
• Severe hepatic dysfunction AST or ALT \> 3 times upper normal reference values) except MI-induced elevation
• Subjects who need antagonist of vitamin K due during study
• Isolated left main disease (lesion(s) at proximal LAD or LCX lesion that need to cross the left main can be enrolled)
• Target lesion(s) with ISR

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Wonju Christian Hospital

Wŏnju, Gangwon-do, 220-050, South Korea

Location

Related Publications (1)

• Youn YJ, Lee JW, Ahn SG, Lee SH, Choi H, Yu CW, Hong YJ, Kwon HM, Hong MK, Jang Y, Yoon J. Multicenter randomized trial of 3-month cilostazol use in addition to dual antiplatelet therapy after biolimus-eluting stent implantation for long or multivessel coronary artery disease. Am Heart J. 2014 Feb;167(2):241-248.e1. doi: 10.1016/j.ahj.2013.08.028. Epub 2013 Oct 22.

  PMID: 24439986 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cilostazol; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines

Study Officials

• Junghan Yoon, M.D., Ph.D.

  Wonju College of Medicine, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junghan Yoon, M.D., Ph.D.

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

KR (1)