Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)
This study has been completed.
Sponsor:
Asan Medical Center
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00446641
First received: March 12, 2007
Last updated: December 10, 2009
Last verified: November 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Infarction |
Drug: Cilostazol Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Aspirin Resistance (ARU ≥ 550) [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Aspirin Resistance (ARU ≥ 500) [ Time Frame: 4 weeks after reatment ] [ Designated as safety issue: No ]
- Bleeding Time (BT) [ Time Frame: 4 weeks after reatment ] [ Designated as safety issue: Yes ]
- Fatal or Major Bleeding Complications; [ Time Frame: events ocurred during study medication after randomization ] [ Designated as safety issue: Yes ]
- Any Bleeding Complications [ Time Frame: events ocurred during study medication after randomization ] [ Designated as safety issue: Yes ]
- Difference of Post-treatment ARU and Baseline ARU [ Time Frame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication ] [ Designated as safety issue: No ]
- Post-treatment ARU [ Time Frame: after 4 weeks treatment ] [ Designated as safety issue: No ]
| Enrollment: | 244 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 Cilostazol
100mg of Cilostazol twice a day
|
Drug: Cilostazol
cilostazol 100mg twice a day for 4 weeks
Other Name: pletaal
|
|
Placebo Comparator: Placebo
matching placebo to cilostazol
|
Drug: placebo
placebo 1 tablet twice a day matching for cilostazol
Other Name: matching placebo of cilostazol
|
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| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446641
Locations
| Korea, Republic of | |
| Jae-Kwan Cha | |
| Busan, Korea, Republic of, 602-715 | |
| Eulji University Hospital | |
| Daejon, Korea, Republic of, 302-799 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Kangdong Sacred Heart Hospital, Hallym University | |
| Seoul, Korea, Republic of, 134-701 | |
Sponsors and Collaborators
Asan Medical Center
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
| Principal Investigator: | Sun U Kwon, MD. PhD. | Asan Medical Center, Univsersity of Ulsan, Medical College |
More Information
No publications provided
| Responsible Party: | Sun U. Kwon, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00446641 History of Changes |
| Other Study ID Numbers: | ARCC |
| Study First Received: | March 12, 2007 |
| Results First Received: | January 22, 2009 |
| Last Updated: | December 10, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
Infarction, Cerebral Cilostazol Aspirin Resistance |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Aspirin |
Cilostazol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013