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Variant AnginaPhase 2STELLANCT01444885

Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina

A Phase 2 study of Variant Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker). Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Variant Angina
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
10 sitesSouth Korea
Study dates
Oct 2011to Jul 2012
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female over the age of 20 and under the age of 80
  • Diagnosis of vasospastic angina
  • At least one episode of chest pain weekly during the Amlodipine run in period for 2 weeks

Who cannot join

  • Currently taking or has taken Cilostazol within the last 3 month before the screening.
  • Taking oral antiplatelet agents such as Aspirin, Clopidogrel after Amlodipine run-in period.
  • Oral anticoagulants such as Warfarin within the last a month before the screening.
  • Currently taking any of the following medications or has taken any of the following medications within the last a week before the screening:
  • Other Calcium channel blockers than Amlodipine
  • Beta-blocker, or Alpha-blocker
Show all 35Show fewer
  • Oral Nitrate, Nicorandil, except sublingual Nitroglycerin as required(PRN)
  • Vitamin E preparations
  • Estrogens
  • History of Myocardial infarction or Myocardial infarction by vasospastic angina at screening
  • History of life threatening vasospastic events such as ventricular tachycardia , ventricular fibrillation, or syncope
  • History of stroke, intracranial hemorrhage, or Transient Ischemic Attack(TIA)
  • Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such tendency (active peptic ulcer, hemorrhagic stroke within past 6 months, a case hemorrhage is suspected by wound for surgery within 3 months, proliferative diabetic retinopathy and uncontrolled hypertension)
  • History of clinically significant hypersensitivity to the substances of Cilostazol, Amlodipine, Nitroglycerin or dihydropyridine
  • Patients with severe aortic valvular stenosis
  • History of shock
  • Hypotension of diastolic pressure < 90 mmHg at screening
  • History of clinically significant hypersensitivity to the substances of Nitrates
  • Patients with severe anemia of Hemoglobin ≤ 6.5 g/dl at screening
  • History of glaucoma
  • Electrocardiogram(ECG) abnormality precluding interpretation of ST change at screening
  • Congestive heart failure with less than 40% of left ventricular ejection fraction within the last 3 month before the screening or screening period
  • Atrial fibrillation or valvular heart disease, more than moderate severity
  • Suspected or identified spasm of left main coronary artery, result of coronary angiography or coronary angiography in the ergonovine induced coronary spasm provocation test
  • History of Coronary artery bypass graft(CABG) or percutaneous coronary intervention(PCI)
  • Tachycardia; Heart rate > 100 bpm, at Screening
  • Uncontrolled hypertension, defined as ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at Screening
  • Creatinine ≥ 1.5 mg/dL at screening
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN) at screening
  • Platelet < 100,000 mm3 at screening
  • QT prolongation defined as baseline QTc > 450 msec for males or > 470 msec for females at Screening.
  • Women who have the possible of pregnancy, or positive urine or blood pregnancy test at screening
  • Women who are not using a reliable method of birth control, who are pregnant, or who are breast-feeding
  • Drug compliance of Amlodipine < 80% during the Amlodipine run in period for 2 weeks
  • Otherwise judged by the investigator to be inappropriate for inclusion in the trial.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

South Korea10 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • ChungNam Univ. Hospital

    Daejeon

  • Gangneung Asan Hospital

    Gangneung

  • Chonnam National University Hospital

    Gwangju

  • Gyongsang National University Hospital

    Jinjoo

  • Dong-A University Hospital

    Pusan

  • Pusan National University Yansan Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • Ajou University Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With Vasospastic Angina (STELLA)

The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).

Read the detailed description

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic exploratory Study.

The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4 weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal (Cilostazol) is used as the control medication.

Conditions
Variant Angina
Being tested
Placebo
Keywords
Variant angina, Cilostazol
Medical subject headings
Angina Pectoris, Variant

What participants receive

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

  • PlaceboDrug

    Also called Amlodipine, Nitroglycerin

    2 weeks treatment of Cilostazol 100mg, or placebo oral tablets bid after 2 weeks treatment of Cilostazol 50mg, or placebo oral tablets bid (Total 4 weeks)

Study groups in NCT01444885
Study groupRoleWhat they receive
CilostazolExperimentalTo investigate the efficacy and safety of Pletaal(Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to Amlodipine (Calcium channel blocker).
Receives: Drug: Placebo

What is being measured

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

  1. Percent change of the chest pain frequency

    Collect the chest pain frequency data related with vasospastic angina episodes by subject diaries.

    Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate.

    Measured: A week before IP dosing and the final a week after IP dosing (average 6weeks)

Secondary outcomes (1)

  1. The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing

    Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate. The subject who has no chest pain will be regarded as the total pain intensity and the average pain intensity are '0'. The subject who has taken no nitroglycerin will be regarded as taking '0' tablet.

    Measured: A week before IP dosing and the final a week after IP dosing (average 6weeks)

Timeline

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

  1. First posted3 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01444885
Sponsor's protocol ID
STELLA
Acronym
STELLA
Status last verified
Jul 2012
First submitted
27 Sep 2011
Last updated
16 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • Shin ES, Lee JH, Yoo SY, Park Y, Hong YJ, Kim MH, Lee JY, Nam CW, Tahk SJ, Kim JS, Jeong YH, Lee CW, Shin HK, Kim JH. A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina. Heart. 2014 Oct;100(19):1531-6. doi: 10.1136/heartjnl-2014-305986. Epub 2014 Jun 16.

    PubMed 24934484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Variant Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 10 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 3 inclusion and 35 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: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change of the chest pain frequency (time frame: A week before IP dosing and the final a week after IP dosing (average 6weeks)). 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 NCT01444885, 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 16 Jul 2012.

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