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PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage

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

Condition(s) targeted: Brain Ischemia; Intracranial Hemorrhages

Intervention: Cilostazol (Drug); Probucol (Drug); Aspirin (Drug); placebo of cilostazol (Drug); placebo of aspirin (Drug); ankle-brachial index (ABI) (Device); intima-medial thickness (IMT) (Device); new asymptomatic brain hemorrhage (Device); new ischemic lesions on follow-up FLAIR images (Device)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Asan Medical Center

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

Summary

Through this study, the investigators are to prove that Cilostazol effectively prevent cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects. The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage. This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic events without increasing the cardiovascular events against aspirin and the superiority of probucol on the prevention of overall cardiovascular events.

Clinical Details

Official title: A Multicenter, Double Blind, Factorial Design, Phase IV Trial to Compare the Efficacy and Safety of Cilostazol Long-term Treatment With Aspirin in Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage for the Prevention of Cerebral Hemorrhage and Cardiovascular Events and to Compare the Preventive Effect of Probucol in the Same Patient Group With Non-drug User Group for the Prevention of Cardiovascular Events

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

Primary outcome:

Time to the first occurrence of cerebral hemorrhage

Time to the first occurence of composite cardiovascular events

Secondary outcome:

Time to the first occurrence of stroke

Time to the first occurrence of ischemic stroke

Time to the first occurence of myocardial infarction

Time to the first occurence of other designated vascular events

Detailed description: It has been generally accepted that 'old age' and 'hypertension' may be risk factors not only for cerebral infarction but also for cerebral hemorrhage. Usually 40 to 60 percent of recurrent strokes after cerebral hemorrhage cases are cerebral infarction; and 5 to 10 percent of recurrent stroke after cerebral infarction cases are cerebral hemorrhage. Consequently, for the reasons described above, hemorrhagic side effects including cerebral hemorrhage have been a great concern, in the usage of antiplatelet agent or anticoagulant for the secondary prevention in the patients with cerebral infarction. It is reported that the occurrence of cerebral hemorrhage tends to increase in cases of accompanying lacunar infarction which occurs more frequently in Asians than in Westerners, or periventricular ischemic change which increasingly occurs with ageing. Accordingly, the point is that the occurrence of cerebral hemorrhage should be primarily considered in the treatment of cerebral infarction, along with the phenomenon of an ageing population both in Asian countries including Korea. Nevertheless, so far there has been no clinical research regarding secondary prevention of stroke, particularly considering the risk of occurrence of hemorrhage in cerebral infarction cases. However, according to a recent study, when phosphodiesterase inhibitors including Cilostazol are used independently, or in combination with aspirin, secondary prevention can be improved without increasing the occurrence of hemorrhagic side effects. Considering this, if it is proved that the agent, Cilostazol, could decrease the risk of occurrence of stoke, along with no significant increase in the risk of occurrence of hemorrhagic side effects, by selecting a patent group with a high risk of cerebral hemorrhage, the agent (Cilostazol) may be recognized as an unique antiplatelet agent applicable to old-aged patient with cerebral infarction who have a certain risk of cerebral hemorrhage.

- High risk of cerebral hemorrhage is defined as presence of history of cerebral

hemorrhage with appropriate neuroimage findings or presence of asymptomatic old cerebral hemorrhage findings(equal or more than 8mm) or multiple microbleeds on the GRE images.

- 1600 ischemic stroke patients with high risk of cerebral hemorrhage will be recruited

and they are randomized into four groups (cilostazol plus probucol, aspirin plus probucol, cilostazol and aspirin) by 2X2 factorial design.

- IMT and ABI will be measured every year during follow-up period and the results will be

compared with the baseline data. The change of IMT and ABI will be analyzed with the occurrence of cardiovascular events.

- The study will finish at least 1 year after the recruit of 1600th patients. Until the

finish, all patients will continuously take study medications and visit every 3months at the study site.

- Brain MRI including FLAIR and GRE will be done at the final visits.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with transient ischemic attack (TIA) or ischemic stroke within 180 days

prior to screening - Adult aged 20 years or older

- High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging

evidence of previous intracranial hemorrhage)

- Informed consent

Exclusion Criteria:

- Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks

- Bleeding tendency

- Pregnant or breast-feeding woman

- Hemorrhagic stroke within 6 months

- Patient who was taking antithrombotic medication other than aspirin and does not

agree to change the previous medication

- Severe cardiovascular disease such as cardiomyopathy or congestive heart failure

- Life expectancy less than one year

- Contraindication to long term aspirin use

- Enrolled in other clinical trial within 30 days

Locations and Contacts

Dong-A University Hospital, Busan, Korea, Republic of

Inje University Pusan Paik Hospital, Busan 614-735, Korea, Republic of

Kosin University Gospel Hospital, Busan 602-702, Korea, Republic of

Pusan National University Hospital, Busan 626-770, Korea, Republic of

Daegu Fatima Hospital, Daegu 701-600, Korea, Republic of

Keimyung University Dongsan Center, Daegu 700-712, Korea, Republic of

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

Deagu Catholic University Hospital, Deagu 705-718, Korea, Republic of

Dongsan Medical Center, Deagu 700-712, Korea, Republic of

Kyungpook National University Hospital, Deagu 700-721, Korea, Republic of

Yeungnam University Medical Center, Deagu 705-717, Korea, Republic of

Chungnam National University Hospital, Deajeon 301-721, Korea, Republic of

Deajeon St.Mary's Hospital, The Catholic University of Korea, Deajeon 303-723, Korea, Republic of

Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of

Chosun University Hospital, GwangJu 501-717, Korea, Republic of

Gachon University Gil Hoapital, Incheon 405-760, Korea, Republic of

Inha University Hospital, Inchon 400-103, Korea, Republic of

Wallace Memorial Baptist Hospital, Pusan 609-728, Korea, Republic of

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

Chung-Ang University Medical Center, Seoul, Korea, Republic of

Eulji Hospital, Seoul 280-1, Korea, Republic of

Ewha Womans University Medical Center, Seoul 158-710, Korea, Republic of

Gangnam Severance Hospital, Seoul 135-720, Korea, Republic of

Hangang Sacred Heart Hospital, Seoul 150-719, Korea, Republic of

Hanyang University Medical Center, Seoul 133-792, Korea, Republic of

Inje University Sanggye Paik Hospital, Seoul 139-707, Korea, Republic of

Kangbuk Samsung Hospital, Seoul 110-746, Korea, Republic of

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

Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 150-950, Korea, Republic of

Konkuk Univ. Hospital, Seoul 143-729, Korea, Republic of

Korea University Anam Hospital, Seoul 136-705, Korea, Republic of

Korea University Guro Hospital, Seoul 152-703, Korea, Republic of

Kyung Hee University Medical Center, Seoul 130-702, Korea, Republic of

National Medical Center, Seoul 100-799, Korea, Republic of

Seoul Medical Center, Seoul 135-740, Korea, Republic of

Seoul National University Borame Hospital, Seoul 156-707, Korea, Republic of

Seoul National University Hospital, Seoul, Korea, Republic of

Seoul St.Mary's Hospital, Seoul 137-701, Korea, Republic of

Severance Hospital, Seoul 120-752, Korea, Republic of

Soonchunhyang University Hospital, Seoul, Korea, Republic of

St. Mary's Hospital, Seoul 150-713, Korea, Republic of

Ulsan University Hospital, Ulsan, Korea, Republic of

Manila Doctors Hospital, Manila, Philippines

University of Santo Tomas, Manila, Philippines

The Medical City, Pasig, Philippines

St. Luke's Medical Center, Quezon City, Philippines

Chungbuk National University Hospital, Cheongju, Chungbuk 361-711, Korea, Republic of

Soonchunhyang University Cheonan Hospital, Cheonan, Chungcheongnam-do 330-721, Korea, Republic of

Wonju Christian Hospital, Wonju, Gangwon-do 220-701, Korea, Republic of

Kwandong University College of Medicine Myongji Hospital, Gyeonggi-do, Goyang 412-270, Korea, Republic of

Gyeongsang National University Hospital, Jinju, Gyengsangnam-do 660-702, Korea, Republic of

Korea University Ansan Hospital, Ansan, Gyeonggi-do 152-703, Korea, Republic of

Soonchunhyang University Bucheon Hospital, Bucheon, Gyeonggi-do 420-020, Korea, Republic of

National Health Insurance Corporation Ilsan Hoapital, Goyang-si, Gyeonggi-do 411-719, Korea, Republic of

Inje University Ilsan Paik Hospital, Goyang, Gyeonggi-do 411-706, Korea, Republic of

Hanyang University Guri Hospital, Guri, Gyeonggi-do 471-701, Korea, Republic of

Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do 463-712, Korea, Republic of

Uijeongbu St. Mary's Hospital, Uijeongbu, Gyeonggi-do 480-821, Korea, Republic of

Samsung changwon Medical Center, Changwon, Gyeongsangnam-do 630-723, Korea, Republic of

Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong, China

Queen Elizabeth Hospital, Hong Kong, Hong Kong, China

United Christian Hospital, Hong Kong, Hong Kong, China

Prince of Wales Hospital, Shatin, NT, Hong Kong, China

Wonkwang University Hospital, Iksan, Jeonbuk 570-711, Korea, Republic of

Chonbuk National University Hospital, Jeonju-si, Jeonbuk 561-712, Korea, Republic of

Kangwon National University Hospital, Chuncheon, Kangwon-do 200-947, Korea, Republic of

Chang Won Fatima hospital, Changwon, Kyeongsangnam-do 641-560, Korea, Republic of

Dongguk University International Hospital, Goyang, Kyoungki-do 410-773, Korea, Republic of

Hallym University Sacred Heart Hospital, Anyang, Kyunggi 430-070, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Kyunggi, Korea, Republic of

Ajou University Hospital, Suwon, Kyunggi, Korea, Republic of

Additional Information

Web-CRF

Starting date: June 2009
Last updated: June 24, 2015

Page last updated: August 23, 2015

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