Pletaal SR Post Marketing Observational Study

Korea Otsuka Pharmaceutical Co., Ltd.3,635 enrolled

Overview

This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.

This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Study Type

OBSERVATIONAL

Enrollment

3,635

Conditions

Ischemic Symptoms Cerebral Infarction

Interventions

This is Non-interventional studyOTHER

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over. 2\. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria. Exclusion Criteria: * Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.

Locations (4)

Kyungpook National University Hospital

Daegu, South Korea

NHIC Ilsan Hospital

Goyang, South Korea

Inje University Seoul Pail Hospital

Seoul, South Korea

Seoul National University

Seoul, South Korea

Outcomes

Primary Outcomes

The Incidence Rate and the Number of AE/ADRs

Incidence rates of overall AEs and ADRs that occurred during the study period

Time frame: Follow-up at least once from baseline to 16 weeks

Secondary Outcomes

The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration

Time frame: Follow-up at least once from baseline to 16 weeks

The Number and Percentage of Drop-out Patients According to Aes

Time frame: Follow-up at least once from baseline to 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.