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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02087007
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Brief 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 period


Condition or disease Intervention/treatment Phase
Vasospastic Angina Drug: Cilostazol Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina Chest Pain
Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: group 1
Cilostazol 50mg, Cilostzaol 100mg
Drug: Cilostazol
100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks

Placebo Comparator: group 2
placebo
Drug: placebo
100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks




Primary Outcome Measures :
  1. Chest Pain Frequency [ Time Frame: Baseline and Week 4 ]
    Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing


Secondary Outcome Measures :
  1. Percent change of the chest pain frequency [ Time Frame: Baseline and Week 4 ]
    Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

  2. Proportion of subjects without chest pain [ Time Frame: 4 weeks ]
    Proportion of subjects without chest pain on the final a week after IP dosing

  3. total chest pain intensity [ Time Frame: Baseline and Week 4 ]
    Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing

  4. average pain intensity(the total pain intensity/the number of pain) [ Time Frame: Baseline and Week 4 ]
    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

  5. total nitroglycerin sublingual consumption [ Time Frame: Baseline and Week 4 ]
    Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  3. 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.
  4. 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)
  5. 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
  5. History of myocardial infarction or with myocardial infarction mediated by vasospastic angina at the time of screening
  6. History of a life-threatening vasospastic event (e.g., ventricular tachycardia, atrial fibrillation or syncope)
  7. History of stroke, intracranial hemorrhage or transient ischemic attack (TIA)
  8. 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)
  9. History of hypersensitivity to the ingredients of Cilostazol, amlodipine, dihydropyridines such as nitroglycerine, and nitrates
  10. Severe aortic stenosis
  11. History of shock
  12. Hypotension with systolic pressure of below 90mmHg at screening
  13. Severe anemia with hemoglobin 6.5g/dl or below at screening
  14. History of glaucoma
  15. ST change abnormality not interpretable on ECG at screening
  16. Congestive heart failure with left ventricular ejection fraction <40% on echocardiography at screening or within the last 3 months
  17. Atrial fibrillation or beyond moderate valvular heart disease
  18. Left main coronary spasm suspected or confirmed by coronary angiography or ergonovine provoked coronary angiography
  19. History of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)
  20. Heart rate >100 bpm at screening via vital sign: tachycardia
  21. Uncontrolled hypertension with systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at screening
  22. Creatinine level ≥ 1.5 mg/dL at screening
  23. AST or ALT > x3 ULN(Upper Limit of Normal) at screening
  24. Platelet count < 100,000mm3 at screening
  25. QT prolongation of QTcB > 450 msec in male and QTcB>470 msec in female subjects at screening
  26. Women of childbearing potential with positive pregnancy test at screening
  27. Women who did not agree to practice a contraceptive measure, pregnant or lactating women
  28. Drug compliance of less than 80% during 2-week amlodipine run-in period
  29. Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
  30. Subjects who used another investigational products within 2 months prior to the randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087007


Locations
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Korea, Republic of
Yangsan Busan University Hospital
Busan, Korea, Republic of, 626-770
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02087007    
Other Study ID Numbers: 021-KOA-1301i
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Treatment for vasospastic angina
Additional relevant MeSH terms:
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Angina Pectoris
Angina Pectoris, Variant
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Angina, Unstable
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors