Health Condition 1: null- Patients undergoing urgent or elective PCI for the prevention of cardiac ischemic complications
Conditions
Interventions
Intervention1: Abciximab code named R-TPR-019: Dose: 0.25 mg/kg intravenous bolus immediately followed by a 0.125 μg/kg/min infusion.
Duration: Over 12 hours.
Abciximab infusion, the bolus should be
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients undergoing urgent or elective PCI for the prevention of cardiac ischemic complications 2 Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures 3 Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate ICF to confirm his/her willingness to continue in the study
Exclusion criteria
Exclusion criteria: 1 Administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia ( 2 Intracranial neoplasm, Arteriovenous malformation or aneurysm. 3 Presumed or documented history of vasculitis 4 Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention 5 CABG or PCI procedure in past history involving the infarct-related artery. 6 Participation in another study with any investigational drug or device within the previous 30 days. 7 Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer). 8 Previous administration of thrombolytics within 7 days. 9 Intolerance or contraindications to acetyl Salicylic Acid. 10 Previous hemorrhagic stroke. 11 Previous ischemic cerebrovascular event within 3 months. 12 Recent major surgery at risk of bleeding. 13 Episodes of uncontrolled hypertension ( >180/110 mmHg despite treatment) in past 2 years. 14 Pregnant and lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be a composite or cumulative incidence of death from any cause, myocardial infarction and re-infarction, or severe myocardial ischemia requiring urgent coronary bypass surgery or repeated percutaneous coronary revascularizationTimepoint: within 30 days after IP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality rateTimepoint: Day 30;Percentage of patients with nonfatal myocardial infarctionTimepoint: within 30 days of IP administration | — |
Countries
India
Contacts
Public ContactDr Parvez Kosgi
Reliance Life Sciences Pvt Ltd
Outcome results
None listed