Coronary Artery DiseasePhase 4NCT01346865
Drug-Eluting Stenting Followed by Cilostazol tREAtment Reduces SErious Adverse Cardiac Events (DECREASE-PCI)
A Phase 4 study testing Cilostazol in people with Coronary Artery Disease, run by Seung-Jung Park at 12 sites in South Korea.
Trial summary
The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with DES for Coronary Artery Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cilostazol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 12 sitesSouth Korea
- Study dates
- May 2011to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical
- Patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible and has been successfully applied for DES implantation
- Age >18 years
- Signed written informed consent form prior to study entry
- 2. Angiographic
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- De novo lesion or restenotic lesions
- Percent diameter stenosis ≥50%
- Reference vessel size 2.5 mm by visual estimation
Who cannot join
- History of bleeding diathesis or coagulopathy (e.g. current use of NSAIDs, Upper GI bleeding during the recent 6 months)
- Pregnancy or lactation (women who have child-bearing potential)
- Known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug of stent
- Limited life-expectancy (less than 1 year) due to combined serious disease
- Characteristics of lesion 1)Left main disease 2)Graft vessels
- Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
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- Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
- Renal dysfunction, creatinine 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- Stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) within 6 months.
- Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Sejong General Hospital
Bucheon-si
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Pusan National University Yangsan Hospital
Pusan
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
Seoul
Gangnam Severance Hospital
Seoul
SMA-SNU Boramae Medical Center
Seoul
St.carollo Hospital
Suncheon
About this study
Official title: A Randomized, Placebo Controlled, Double-blind, Phase 4 Study to Evaluate Efficacy and Safety of Triple Anti-platelet Therapy Compared With Dual Antiplatelet Therapy in Patients Treated With Drug Eluting Stent for Coronary Artery Disease
The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with DES for Coronary Artery Disease.
The primary objective of this study is to compare the safety and efficacy of triple antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with drug-eluting stent (DES) implantation for the treatment of coronary artery disease.
Read the detailed description
Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents (BMS). Therefore, DES implantation has been default strategy in the treatment of coronary artery disease. However, despite use of DES, the restenosis, subsequent repeat revascularization, and associated cardiac events (stent thrombosis, myocardial infarction) remain significant clinical problem in routine practice, especially complex lesion subsets.
2110 patients who received successful dug eluting stent implantation will be enrolled at 21 centers in Korea. Patients meeting inclusion criteria without any exclusion criteria and agree to participate in this trial will be randomized 1:1 to a) triple therapy (Aspirin+Clopidogrel +Cilostazol) or b) dual therapy group (Aspirin+ Clopidogrel +Placebo). All patients will be blindly assigned to cilostazol 100mg (1tablet bid) or matching placebo (1tablet bid) as 1:1 ratio and are prescribed for 1 year.
- Conditions
- Coronary Artery Disease
- Being tested
- Cilostazol, Placebo
- Keywords
- triple anti-platelet therapy, dual antiplatelet therapy, DES, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called Pletaal
Cilostazol 100mg bid
PlaceboDrug
Placebo 1tablet bid
| Study group | Role | What they receive |
|---|---|---|
| cilostazol | Experimental | cilostazol 100mg Receives: Drug: Cilostazol |
| dual therapy group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization
Measured: At 1-year time point after PCI
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE)
- Composite of major cardiac adverse events (MACE) including death, Q-MI, Non Q- MI, and target lesion or vessel revascularization
- Target vessel revascularization
- Target lesion revascularization
- Stent thrombosis (definite/probable)
- Ischemic stroke
- Myocardial infarction
- Adverse Events during study periods
Measured: At 1-year time point and yearly up to 3 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346865
- Sponsor's protocol ID
- CVRF2010-10
- Status last verified
- Nov 2015
- First submitted
- 22 Apr 2011
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double-blind, Phase 4 Study to Evaluate Efficacy and Safety of Triple Anti-platelet Therapy Compared With Dual Antiplatelet Therapy in Patients Treated With Drug Eluting Stent for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01346865
- Acronym / sponsor ID
- CVRF2010-10
- Conditions
- Coronary Artery Disease
- Keywords
- triple anti-platelet therapy, dual antiplatelet therapy, DES, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- May 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with DES for Coronary Artery Disease.
The primary objective of this study is to compare the safety and efficacy of triple antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with drug-eluting stent (DES) implantation for the treatment of coronary artery disease.
Detailed description
Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents (BMS). Therefore, DES implantation has been default strategy in the treatment of coronary artery disease. However, despite use of DES, the restenosis, subsequent repeat revascularization, and associated cardiac events (stent thrombosis, myocardial infarction) remain significant clinical problem in routine practice, especially complex lesion subsets.
2110 patients who received successful dug eluting stent implantation will be enrolled at 21 centers in Korea. Patients meeting inclusion criteria without any exclusion criteria and agree to participate in this trial will be randomized 1:1 to a) triple therapy (Aspirin+Clopidogrel +Cilostazol) or b) dual therapy group (Aspirin+ Clopidogrel +Placebo). All patients will be blindly assigned to cilostazol 100mg (1tablet bid) or matching placebo (1tablet bid) as 1:1 ratio and are prescribed for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cilostazol | Experimental | Drug: Cilostazolcilostazol 100mg |
| dual therapy group | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Clinical
- Patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible and has been successfully applied for DES implantation
- Age >18 years
- Signed written informed consent form prior to study entry
Key exclusion criteria (11 listed)
- History of bleeding diathesis or coagulopathy (e.g. current use of NSAIDs, Upper GI bleeding during the recent 6 months)
- Pregnancy or lactation (women who have child-bearing potential)
- Known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug of stent
- Limited life-expectancy (less than 1 year) due to combined serious disease
- Characteristics of lesion 1)Left main disease 2)Graft vessels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CilostazolAlso: PletaalCilostazol 100mg bid | Drug | cilostazol |
| PlaceboPlacebo 1tablet bid | Drug | dual therapy group |
Primary outcome
Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
Time frame: At 1-year time point after PCI
composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization
1 secondary outcome
Major Adverse Cardiac Events (MACE)
Time frame: At 1-year time point and yearly up to 3 years after PCI
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Department of Medicine, Asan Medical Center University of Ulsan College of Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol in people with Coronary Artery Disease, run by Seung-Jung Park at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE) (time frame: At 1-year time point after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.