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Vasospastic AnginaPhase 3STELLANCT02087007

A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina

A Phase 3 study testing Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site 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

This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA. Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up… Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Vasospastic Angina
What is being tested?
Cilostazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSouth Korea
Study dates
Nov 2013to Jul 2015
Phase
Phase 3
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

  1. Male or female 20 or over the age of 20 and under the age of 80.
  2. Patients showing angina attack even while resting during the screening, diagnosed with vasospastic angina within the previous 3 months by meeting at least one of the 3 definitions, and accompanying insignificant (stenosis rate <50%) coronary artery disease documented by coronary angiography within the last 3 months [temporary antispastic agents (monotherapies or a combination of Verapamil and Nitroglycerin, anticoagulants) for coronary angiography are allowed]
  • Chest pain accompanied by at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater in the absence of ergonovine provoked coronary angiography.
  • Positive Intracoronary (IC) or Intravenous (IV) Ergonovine provocation test; ischemic ECG change accompanied by chest pain and spasm reducing the coronary diameter by 90% or more (at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater on 12-lead ECG)
  1. Patients who reported at least 1 episode of chest pain in a week during amlodipine run-in period and at least 2 episodes in the final week.
  2. Women who had been menopausal or sterile for at least 1 year, or women of childbearing potential who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
  3. Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial.

Subjects presenting with any of the following will not be included in the study:

  1. Subjects who used Cilostazol within 3 months before the screening visit
  2. Subjects who used antiplatelet drugs, including Aspirin, Clopidogrel, Ticlopidine and Sarpogrelate, or PDE3 inhibitors of the same class as Cilostazol, such as Amrinone, Milrinone and Enoximone, after the initiation of the amlodipine run-in period
  3. Subjects who used oral anticoagulants, such as warfarin, within 1 months prior to the screening visit
  4. Subjects who used any of the following drugs within 1 week prior to the screening visit
  • CCBs apart from amlodipine
  • Beta-blockers or alpha-blockers
  • Oral nitrate, excluding nitroglycerin sublingual tablet, Nicorandil
  • Vitamin E preparations
  • Estrogens
  1. History of myocardial infarction or with myocardial infarction mediated by vasospastic angina at the time of screening
  2. History of a life-threatening vasospastic event (e.g., ventricular tachycardia, atrial fibrillation or syncope)
  3. History of stroke, intracranial hemorrhage or transient ischemic attack (TIA)
  4. Hemorrhage (hemophilia, capillary fragility, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.) or such predisposition (active peptic ulcer, hemorrhage suspected at Cilostazol administration for surgical wound within the last 3 months, proliferative diabetic retinopathy)
  5. History of hypersensitivity to the ingredients of Cilostazol, amlodipine, dihydropyridines such as nitroglycerine, and nitrates
  6. Severe aortic stenosis
  7. History of shock
  8. Hypotension with systolic pressure of below 90mmHg at screening
  9. Severe anemia with hemoglobin 6.5g/dl or below at screening
  10. History of glaucoma
  11. ST change abnormality not interpretable on ECG at screening
  12. Congestive heart failure with left ventricular ejection fraction <40% on echocardiography at screening or within the last 3 months
  13. Atrial fibrillation or beyond moderate valvular heart disease
  14. Left main coronary spasm suspected or confirmed by coronary angiography or ergonovine provoked coronary angiography
  15. History of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)
  16. Heart rate >100 bpm at screening via vital sign: tachycardia
  17. Uncontrolled hypertension with systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at screening
  18. Creatinine level ≥ 1.5 mg/dL at screening
  19. AST or ALT > x3 ULN(Upper Limit of Normal) at screening
  20. Platelet count < 100,000mm3 at screening
  21. QT prolongation of QTcB > 450 msec in male and QTcB>470 msec in female subjects at screening
  22. Women of childbearing potential with positive pregnancy test at screening
  23. Women who did not agree to practice a contraceptive measure, pregnant or lactating women
  24. Drug compliance of less than 80% during 2-week amlodipine run-in period
  25. Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
  26. Subjects who used another investigational products within 2 months prior to the randomization

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Yangsan Busan University Hospital

    Busan, 626-770

Other trials in South Korea

About this study

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

This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA.

Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period

Read the detailed description

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

The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets 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.

Being tested
Cilostazol, placebo
Keywords
Treatment for vasospastic angina
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.

  • CilostazolDrug

    100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks

  • placeboDrug

    100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks

Study groups in NCT02087007
Study groupRoleWhat they receive
group 1ExperimentalCilostazol 50mg, Cilostzaol 100mg
Receives: Drug: Cilostazol
group 2Placebo comparatorplacebo
Receives: Drug: placebo

What is being measured

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

  1. Chest Pain Frequency

    Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

    Measured: Baseline and Week 4

Secondary outcomes (5)
  1. Percent change of the chest pain frequency

    Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

    Measured: Baseline and Week 4

  2. Proportion of subjects without chest pain

    Proportion of subjects without chest pain on the final a week after IP dosing

    Measured: 4 weeks

  3. total chest pain intensity

    Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing

    Measured: Baseline and Week 4

  4. average pain intensity(the total pain intensity/the number of pain)

    Change of the average pain intensity(the total pain intensity/the number of pain) on the final a week after IP dosing from a week before IP dosing

    Measured: Baseline and Week 4

  5. total nitroglycerin sublingual consumption

    Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing

    Measured: Baseline and Week 4

Timeline

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

  1. First posted14 Mar 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2015
  4. Study completionJul 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087007
Sponsor's protocol ID
021-KOA-1301i
Acronym
STELLA
Status last verified
May 2017
First submitted
17 Feb 2014
Last updated
4 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. 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?

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 4 May 2017. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Chest Pain Frequency (time frame: Baseline and Week 4). 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 4 May 2017.

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