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Acute Myocardial InfarctionPhase 4SILOAMNCT01261832

Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients

A Phase 4 study testing antiplatelet therapy in people with Acute Myocardial Infarction, run by Korea University Guro Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
antiplatelet therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
951 participants
Where
1 siteSouth Korea
Study dates
Jul 2011to Mar 2022
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

None listed.

Who cannot join

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol
  • Uncontrolled hypertension
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
  • Baseline hemogram with Hb<10g/dL or PLT count<100,000/μL
  • Patients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Randomized, Prospective , Open Label, Phase 4 Trial of Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention With Drug-eluting Stent

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.

Read the detailed description

Drug-eluting stents (DES) have drastically changed the landscape of percutaneous coronary intervention (PCI), with significant reductions in the angiographic restenosis rate and need for repeated revascularization. However, several studies showed that DES is associated with a higher incidence of in-stent thrombosis compared with bare metal stents. Therefore, the latest guideline for antiplatelet therapy after PCI with DES suggests that the dual antiplatelet therapy (aspirin plus clopidogrel) be administered for at least 12 months.But is it enough for high-risk patients? Some studies showed that as many as 50% of the patients who received PCI did not react positively to aspirin or clopidogrel.Furthermore, there is increased platelet activity in acute coronary syndrome, especially in acute myocardial infarction (AMI). compared with aspirin or clopidogrel.A recent study suggested that cilostazol could ameliorate platelet responsiveness to clopidogrel in patients who underwent primary PCI. Furthermore, some other studies showed that the administration of cilostazol after PCI could significantly lower the incidence of in-stent restenosis. Therefore, the present study is designed to evaluate the safety and efficacy of additional administration of cilostazol with aspirin and clopidogrel in a real-world cardiology practice among patients presenting with AMI who received primary PCI with DES.

Being tested
antiplatelet therapy
Keywords
Acute Myocardial Infarction, Percutaneous coronary intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • antiplatelet therapyDrug

    Also called The brand name of clopidogrel is Plavix., The brand name of cilostazol is Pletaal.

    Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.

Study groups in NCT01261832
Study groupRoleWhat they receive
Dual antiplatelet therapy for 1 yearExperimentalDual antiplatelet therapy for 1 year : dual antiplatelet combination therapy with aspirin and clopidogrel for 1 year
Receives: Drug: antiplatelet therapy
Triple antiplatelet therapy for 1 monthExperimentalTriple antiplatelet therapy for 1 month : triple antiplatelet therapy including cilostazol for 1 month and after then, dual antiplatelet therapy for 11 months
Receives: Drug: antiplatelet therapy
Triple antiplatelet therapy for 6 monthsExperimentalTriple antiplatelet therapy for 6 months : triple antiplatelet combination therapy including cilostazol for 6 months and after then, dual antiplatelet therapy for 6 months and cilostazol
Receives: Drug: antiplatelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiovascular and Cerebral Events

    Composite of total death, Nonfatal Myocardial Infarction (Non-QMI , Q-MI), Repeat RevascularizationI (Target Vessel Revascularization +Non Target Vessel Revascularization , Coronary Artery Bypass Graft), Stroke (Ischemic \& Hemorrhagic)

    Measured: One Year

Secondary outcomes (1)

  1. Individual outcome of primary end points, Stent thrombosis,Bleeding Complication,PFT (Platelet function test),Genotyping results

    1. Individual outcome of primary end points
    2. Stent thrombosis
    3. Beeding Complication defined by the TIMI criteria \& Minor Bleeding, Vascular Complications
    4. Angiographic outcomes at 1 year : Binary restenosis, Late loss, FU MLD, mean % restenosis, restenosis type
    5. IVUS findings at Index and Follow up angiography
    6. PFT (Platelet function test) : at discharge, intercurrent event , after one year
    7. Genotyping results : genetic polymorphism

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study startJul 2011
  3. Primary completionFeb 2020
  4. Study completionMar 2022 (estimated)

Resources

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
None (open label)
Enrolment
951 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261832
Sponsor's protocol ID
KoreaUGuroH SILOAM
Acronym
SILOAM
Status last verified
Feb 2020
First submitted
16 Dec 2010
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen KY, Rha SW, Li YJ, Poddar KL, Jin Z, Minami Y, Wang L, Kim EJ, Park CG, Seo HS, Oh DJ, Jeong MH, Ahn YK, Hong TJ, Kim YJ, Hur SH, Seong IW, Chae JK, Cho MC, Bae JH, Choi DH, Jang YS, Chae IH, Kim CJ, Yoon JH, Chung WS, Seung KB, Park SJ; Korea Acute Myocardial Infarction Registry Investigators. Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation. 2009 Jun 30;119(25):3207-14. doi: 10.1161/CIRCULATIONAHA.108.822791. Epub 2009 Jun 15.

    PubMed 19528339

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing antiplatelet therapy in people with Acute Myocardial Infarction, run by Korea University Guro Hospital at 1 site 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 0 inclusion and 7 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Major Adverse Cardiovascular and Cerebral Events (time frame: One Year). 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 NCT01261832, 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 20 Feb 2020.

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