Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy
Brief Summary: Background:

Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.

Methods/Design:

Present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.

Discussion:

As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.


Options:
A: Inclusion Criteria:

* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped
B: Inclusion Criteria:

* Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (\>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
* Females of child-bearing potential must have a negative pregnancy test at enrollment
* Persons who are currently taking aspirin between 75 and 150 mg once daily

Exclusion Criteria:

* Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
* Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
* Persons with known bleeding disorders
* Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
* Persons with a history of ischemic stroke
* Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
* Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
* Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
* Persons with known severe liver disease
* Persons with kidney failure requiring dialysis
* Persons with life expectancy \< 1 year
C: Inclusion Criteria:

* patient with chronic kidney disease scheduled for coronary angiogram

Exclusion Criteria:

* age less than 20 years or more than 85 years
* liver cirrhosis greater than or equal to Child class B
* decreased serum platelet level (\< 100,000/uL)
* patients who received or are schedule to receive percutaneous renal intervention
* currently are taking anticoagulation drugs
* unable to give informed consent
D: Inclusion Criteria:

Any one or more of the following:

Meet Angiographic criteria plus

* Systemic hypertension at baseline, or a history of hypertension
* Congestive heart failure at baseline, or a history of CHF
* Renal insufficiency at baseline, or a history of renal insufficiency
* Angina, or a history of angina

Exclusion Criteria:

* Less than 18 years old
* Contraindications to device/drug

Answer: C