Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance

WikiDoc Resources for Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Articles
Most recent articles on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Most cited articles on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Review articles on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Articles on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance in N Eng J Med, Lancet, BMJ
Media
Powerpoint slides on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Images of Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Photos of Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Podcasts & MP3s on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Videos on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Evidence Based Medicine
Cochrane Collaboration on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Bandolier on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance TRIP on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Clinical Trials
Ongoing Trials on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance at Clinical Trials.gov Trial results on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Clinical Trials on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance at Google
Guidelines / Policies / Govt
US National Guidelines Clearinghouse on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance NICE Guidance on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance NHS PRODIGY Guidance FDA on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance CDC on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Books
Books on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
News
Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance in the news Be alerted to news on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance News trends on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Commentary
Blogs on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Definitions
Definitions of Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Patient Resources / Community
Patient resources on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Discussion groups on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Patient Handouts on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Directions to Hospitals Treating Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Risk calculators and risk factors for Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Healthcare Provider Resources
Symptoms of Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Causes & Risk Factors for Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Diagnostic studies for Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance Treatment of Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Continuing Medical Education (CME)
CME Programs on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
International
Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance en Espanol Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance en Francais
Business
Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance in the Marketplace Patents on Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Experimental / Informatics
List of terms related to Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance

Complete Title of Study

A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-Blind Trial of Clopidogrel Versus Placebo in High-Risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-Dose ASA.

Study Acronym (The trial's abbreviation if there is one)

CHARISMA

Principal Investigator, Co-investigators, and Collaborating Institutions

Study Director: ICD CSD Sanofi-Aventis

Overview of Trial

The goal of the study is to compare the efficacy of 75mg once daily clopidogrel with placebo in preventing major cardioavasular events (stroke, MI, cardiovascular death) in high risk patients on a low-dose aspirin therapy (75-162 mg daily) and to compare rates of major and fatal bleeding between the clopidogrel and placebo groups.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)

Arteriosclerosis

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here

Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)

None reported

Primary Pre-Specified Endpoint

Combined endpoint of cardiovascular mortality, stroke, acute myocardial infarction.

Secondary Endpoints

Severe bleeding

Inclusion Criteria

• Be at least 45 years old and comply with at least one of the four categories of inclusion criteria:
  • Combination of atherothrombotic risk factors (2 major or 3 minor or 1 major + 2 minor risk factors among those listed below)

• Major atherothrombotic risk factors
  • Type I or II diabetes (under drug therapy)
  • Diabetic nephropathy
  • Ankle brachial index (ABI) < 0.9
  • Asymptomatic carotid stenosis >= 70%
  • At least one carotid plaque as evidenced by intima-media thickness (IMT)

• Minor atherothrombotic risk factors
  • Systolic blood pressure (SBP) >= 150 mmHg, despite appropriate therapy for at least 3 months
  • Primary hypercholesterolemia
  • Current smoking > 15 cigarettes per day
  • Male >= 65 years
  • Female >= 70 years

• and/or
  • Documented cerebrovascular disease (TIA or IS within 5 years) and/or
  • Documented coronary artery disease (stable angina with documented multivessel coronary disease, previous documented MI, multivessel PCI or CABG within 1 year, multivessel CABG older than 1 year associated with current angina) and/or
  • Documented symptomatic PAD

Exclusion Criteria

• Absolute indication for the use of clopidogrel, high-dose aspirin (>162 mg), NSAIDs, or oral anti-thrombotic drugs
• Absolute contraindication to the use of clopidogrel or aspirin
• Clinical conditions likely to interfere with follow-up leading to inability to complete the trial

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)

None reported

Conclusions of the Investigators (Quote the investigators conclusions here)

None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)

None reported

Slides

None reported

Video Commentary

None reported

References (How to insert a reference)

None reported

External sites for further information (How to insert links)

None reported

Ages

__ years to ___ years

Gender (Indicate whether men, women or both were enrolled)

None reported

Accepts Healthy Volunteers (Answer yes or no)

None reported

Enrollment Period (Study start and end date)

None reported

Recruitment Status (explanation)

None reported

Enrollment (Total number of patients enrolled)

None reported

Study Sponsor (e.g. Investigator initiated or company name)

None reported (this may not have yet been ascertained)

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)

None reported

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov. Template:SIB Template:WH