CTRI/2009/091/001085已完成3 期
AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF PRASUGREL IN COMPARISON WITH CLOPIDOGREL IN ACUTE CORONARY SYNDROME (ACS) PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) Acronym: PRIVILEGE PCI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria: Patients meeting all below mentioned criteria
- •(1) Male or female patients in the age group of 18to74 years.
- •(2) Diagnosed cases of Acute coronary syndrome (ACS) patients (with TIMI RISK Score greater or equal to 3) selected for elective PCI.
- •(3) Patients willing to give informed consent.
排除标准
- •Exclusion Criteria: Patients meeting any of the following criteria:
- •(1) Cardiovascular exclusion criteria:
- •- Patients with cardiogenic shock at the time of randomization.
- •- Patients with severe heart failure (class III & IV according to Killip classification).
- •- Patients with refractory ventricular arrhythmias.
- •(2) Bleeding & related risk exclusion criteria:
- •- Patients who have received fibrin specific fibrinolytic therapy less than 24 hours before randomization.
- •- Patients who have received non-fibrin specific fibrinolytic therapy less than 48 hours before randomization.
- •- Patients with active internal bleeding.
- •- Patients with propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding or active peptic ulcer disease, or patients with known intracranial neoplasm, arteriovenous malformation , aneurysm, international normalized ration (INR) > 1.5, platelet count < 100,000/mm3).
- •- Patients with history of hemorrhagic cerebrovascular accident.
- •- Patients with ischemic stroke within 03 months prior to screening.
- •- Patients with anaemia (Hb less than 10 gm/dl) at the time of screening.
- •- Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •(3) Concomitant or prior drug therapy exclusion criteria
- •- Patients receiving or who are likely to receive oral anti-coagulation therapy that cannot be safely discontinued for the duration of the trial.
- •- Patients receiving daily treatment of NSAIDs or cyclooxygenase-2 inhibitors that can not be discontinued.
- •(4) General exclusion criteria
- •- Patients with intolerance of or allergy to thienopyridine.
- •- Patients who has a severe liver disease, such as cirrhosis.
- •- Patients with elevated serum creatinine more than 1.5 times ULN.
- •- Females who are known to be pregnant, have given birth within the past 90 days, or are breastfeeding or unwilling to practice birth control measures during the study duration.
- •- Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period.
- •- Any condition associated with poor treatment compliance, including alcoholism, mental illness or drug dependence.
- •- Patients with body weight < 60 kg.
研究者
相似试验
已完成
3 期
6-WEEK TRIAL OF THE EFFICACY AND SAFETY OF ASENAPINE COMPARED TO RISPERIDONE IN ADULT PATIENT WITH ACUTE EXACERBATION OF SCHIZOPHRENIACTRI/2010/091/000423Intas Pharmaceuticals Limited280
Unknown
3 期
13-WEEK STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 TABLET COMPARED TO OXCARBAZEPINE SUSTAINED-RELEASE TABLET AS ADJUNCTIVE TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURESCTRI/2010/091/006085Intas Pharmaceuticals Limited270
Unknown
3 期
PHASE III CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-PHRM-001 IN COMPARISON WITH ALLOPURINOL IN ADULT PATIENTS WITH GOUT.CTRI/2009/091/001087Intas Pharmaceuticals Limited270
已完成
3 期
Phase III clinical trial for Evaluation of Efficacy and Safety of IN-PHARM-002 in Comparison with Ibuprofen in adult patients with acute painful soft tissue injury.CTRI/2009/091/001067Intas Pharmaceuticals Limited204
尚未招募
2 期
A clinical study to evaluate effectiveness of Unani formulations in TineaCTRI/2020/04/024765ational Research Institute of Unani Medicine for Skin Disorders