Myocardial Infarction, AcutePhase 4EPISODENCT04407312
Cilostazol and Endothelial Progenitor Cell
A Phase 4 study testing Cilostazol Tablets, Aspirin and Clopidogrel in people with Myocardial Infarction, Acute, run by Gyeongsang National University Hospital.
Trial summary
To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization in patients with acute myocardial infarction (To reveal the role of cilostazol in up-regulation of EPC count) Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Cilostazol Tablets, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jul 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- naïve AMI
- undergoing successful coronary stent implantation
Who cannot join
- high-risk patients for thrombotic event;
- a history of active bleeding or bleeding diatheses;
- contraindication to antiplatelet therapy;
- hemodynamic or electrical instability;
- oral anticoagulation therapy;
- left ventricular ejection fraction < 30%;
Show all 14Show fewer
- leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3;
- AST or ALT > 3 times the respective the upper limit;
- serum creatinine level > 3.5 mg/dL;
- stroke within 3 months;
- pregnancy;
- non-cardiac disease with a life expectancy < 1 year;
- any patients not tolerable or suitable for coronary intervention; and
- inability to follow the protocol
About this study
Official title: Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients With Acute Myocardial Infarction: A Randomized, Placebo-controlled ACCEL-EPISODE Trial
To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization in patients with acute myocardial infarction (To reveal the role of cilostazol in up-regulation of EPC count)
Read the detailed description
Primary endpoint: % Change of EPC count
Secondary endpoints:
- Changes of ADP/AA/collagen-induced PFT
- Changes of lipid profile and high sensitivity-C-reactive protein
- Change of TEG measurements
- Change of PWV
- Predictors of EPC count (baseline and 1-month)
- ischemic (CV death, MI \& stroke) and bleeding events (BARC)
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Cilostazol Tablets, placebo, Aspirin, Clopidogrel
- Keywords
- Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol TabletsDrug
Also called Cilostazol-SR
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
placeboDrug
Placebo, tablet, 200mg, once daily, 30 days.
AspirinDrug
Also called Astrix
Astrix, capsule,100mg, once daily, 30 days.
ClopidogrelDrug
Also called Plavix
Plavix, tablet, 75mg, once daily, 30 days.
| Study group | Role | What they receive |
|---|---|---|
| CILO group | Experimental | Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily. Receives: Drug: Cilostazol Tablets; Drug: Aspirin; Drug: Clopidogrel |
| Placebo group | Placebo comparator | Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily. Receives: Drug: placebo; Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline CD133+/KDR+ at 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
Measured: baseline and 30 days
Changes from baseline CD34+/KDR+ at 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
Measured: baseline and 30 days
Secondary outcomes (4)
Levels of Platelet inhibition
Platelet function test by VerifyNow assay at 30-day follow-up
Measured: baseline and 30 days
Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
the correlation between the changes of EPC subsets and ∆Platelet reactivity unit (PRU) by Pearson's method
Measured: baseline and 30 days
Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
the correlation between the changes of EPC subsets and ∆PRU by Pearson's method
Measured: baseline and 30 days
Incidence of bleeding events by BACR definition
Safety outcome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yongwhi Park, MD, PhD., Gyeongsang National University Hospital
- Investigators
- Young-Hoon Jeong, MD,.PhD, Principal investigator, Gyeongsang National University Changwon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407312
- Sponsor's protocol ID
- GNUHIRB 2012-01-005
- Acronym
- EPISODE
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park Y, Kim JH, Kim TH, Koh JS, Hwang SJ, Hwang JY, Jeong YH. Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial. J Clin Med. 2020 Jun 1;9(6):1678. doi: 10.3390/jcm9061678.
PubMed 32492942
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients With Acute Myocardial Infarction: A Randomized, Placebo-controlled ACCEL-EPISODE Trial
- ClinicalTrials.gov ID
- NCT04407312
- Acronym / sponsor ID
- EPISODE / GNUHIRB 2012-01-005
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Endothelial progenitor cell, Myocardial infarction, acute, Platelets, Cilostazol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 29 May 2020 (actual)
- 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.
To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization in patients with acute myocardial infarction (To reveal the role of cilostazol in up-regulation of EPC count)
Detailed description
Primary endpoint: % Change of EPC count
Secondary endpoints:
- Changes of ADP/AA/collagen-induced PFT
- Changes of lipid profile and high sensitivity-C-reactive protein
- Change of TEG measurements
- Change of PWV
- Predictors of EPC count (baseline and 1-month)
- ischemic (CV death, MI \& stroke) and bleeding events (BARC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CILO group | Experimental | Drug: Cilostazol Tablets, Drug: Aspirin, Drug: ClopidogrelIntervention: Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room. After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence. For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily). Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial. Drug: Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily. |
| Placebo group | Placebo comparator | Drug: placebo, Drug: Aspirin, Drug: ClopidogrelIntervention: Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room. After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence. In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily). Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial. Drug: Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- naïve AMI
- undergoing successful coronary stent implantation
Key exclusion criteria (14 listed)
- high-risk patients for thrombotic event;
- a history of active bleeding or bleeding diatheses;
- contraindication to antiplatelet therapy;
- hemodynamic or electrical instability;
- oral anticoagulation therapy;
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 |
|---|---|---|
| Cilostazol TabletsAlso: Cilostazol-SRCilostazol-SR, capsule, 200mg, once daily, 30 days. | Drug | CILO group |
| placeboPlacebo, tablet, 200mg, once daily, 30 days. | Drug | Placebo group |
| AspirinAlso: AstrixAstrix, capsule,100mg, once daily, 30 days. | Drug | CILO group, Placebo group |
| ClopidogrelAlso: PlavixPlavix, tablet, 75mg, once daily, 30 days. | Drug | CILO group, Placebo group |
Primary outcome
Changes from baseline CD133+/KDR+ at 30 days
Time frame: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
Changes from baseline CD34+/KDR+ at 30 days
Time frame: baseline and 30 days
Peripheral blood mononuclear cells measurement by flow cytometry
4 secondary outcomes
Levels of Platelet inhibition
Time frame: baseline and 30 days
Correlation between the changes of CD133+/KDR+ and platelet reactivity unit by VerifyNow by Pearson's method
Time frame: baseline and 30 days
Correlation between the changes of CD34+/KDR+ and platelet reactivity unit by VerifyNow
Time frame: baseline and 30 days
Incidence of bleeding events by BACR definition
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 32492942Park Y, Kim JH, Kim TH, Koh JS, Hwang SJ, Hwang JY, Jeong YH. Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial. J Clin Med. 2020 Jun 1;9(6):1678. doi: 10.3390/jcm9061678.
- Individual participant dataSharing planned: No
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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.
Young-Hoon Jeong, MD,.PhD principal investigator
Gyeongsang National University Changwon Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol Tablets, Aspirin and Clopidogrel in people with Myocardial Infarction, Acute, run by Gyeongsang National University Hospital.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Changes from baseline CD133+/KDR+ at 30 days (time frame: baseline and 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407312, which also lists 1 linked publication.
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 29 May 2020.