Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Cerebral Infarction Clinical Trial

— ARCC  

Official title:

Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446641
• Other study ID #: ARCC
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2007
• Last updated: December 10, 2009
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2009
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will recruit 316 ischemic stroke patients taking aspirin.

They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.

The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

Description:

[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.

[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

[Participants] Ischemic stroke patients taking aspirin

[Methods]

• Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

• Investigational product: Cilostazol 200mg (100mg twice per day)

• Concomitant medication: Aspirin 100 mg per day

• Medication Duration: 1 month

[Outcome Variables]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

• the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA

• ARUs values

• Bleeding time (BT)

• Fatal or major bleeding complications

• Any bleeding complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic cerebral infarction documented on MRI or CT

• More than 35 years of age

• Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria:

• Patients taking any antiplatelets other than aspirin within 2 weeks before randomization

• Patients taking any anticoagulants within 2 weeks before randomization

• Patients taking thrombolytic therapy within 2 weeks before randomization

• Patients taking any NSAIDs within 2 weeks before randomization

• Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).

• Bleeding diathesis

• Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)

• Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)

• Pregnant or lactating patients

• Patients scheduled for angioplasty or revascularization procedures within 4 weeks

• Patients scheduled for any surgery or invasive procedures within 4 weeks

• Patients having acute coronary syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Cilostazol
cilostazol 100mg twice a day for 4 weeks
• placebo
placebo 1 tablet twice a day matching for cilostazol

Locations

Country	Name	City	State
Korea, Republic of	Jae-Kwan Cha	Busan
Korea, Republic of	Eulji University Hospital	Daejon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital, Hallym University	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspirin Resistance (ARU = 550)		4 weeks after treatment	No
Secondary	Aspirin Resistance (ARU = 500)		4 weeks after reatment	No
Secondary	Bleeding Time (BT)		4 weeks after reatment	Yes
Secondary	Fatal or Major Bleeding Complications;		events ocurred during study medication after randomization	Yes
Secondary	Any Bleeding Complications		events ocurred during study medication after randomization	Yes
Secondary	Difference of Post-treatment ARU and Baseline ARU		baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication	No
Secondary	Post-treatment ARU		after 4 weeks treatment	No