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Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction

Intervention: Cilostazol (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Sun U Kwon, MD. PhD., Principal Investigator, Affiliation: Asan Medical Center, Univsersity of Ulsan, Medical College

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.

Clinical Details

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

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

Primary outcome: Aspirin Resistance (ARU ≥ 550)

Secondary outcome:

Aspirin Resistance (ARU ≥ 500)

Bleeding Time (BT)

Fatal or Major Bleeding Complications;

Any Bleeding Complications

Difference of Post-treatment ARU and Baseline ARU

Post-treatment ARU

Detailed 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

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jae-Kwan Cha, Busan 602-715, Korea, Republic of

Eulji University Hospital, Daejon 302-799, Korea, Republic of

Asan Medical Center, Seoul 138-736, Korea, Republic of

Kangdong Sacred Heart Hospital, Hallym University, Seoul 134-701, Korea, Republic of

Additional Information

Starting date: March 2007
Last updated: December 10, 2009

Page last updated: August 23, 2015

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