Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00821834
Brief Summary:
Primary objective:
* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.
Secondary objectives:
* To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
* To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
* To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
* To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.
Detailed Description:
The study consisted of two periods:
* a double blind treatment period of 12 weeks followed by,
* an open label clopidogrel treatment period in a subset of patients.
All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
Study:
NCT00821834
Study Brief:
Protocol Section:
NCT00821834