Table 2 Primary and secondary end points

From: Rationale, study design and implementation of the COLM study: the combination of OLMesartan and calcium channel blocker or diuretic in high-risk elderly hypertensive patients

Primary end point

A composite of fatal and non-fatal cardiovascular events

1. Sudden death (death of endogenous origin within 24 h after acute onset)

2. Cerebrovascular events (new occurrence or recurrence of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack)

3. Cardiac events (new occurrence or recurrence of myocardial infarction, coronary revascularization (PCI or CABG), hospitalization for angina pectoris or hospitalization for heart failure)

4. Renal dysfunction (doubling of serum creatinine and creatinine ⩾2.0 mg per 100 ml, ESRD)

Secondary end points

1. Composite of hard endpoint: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke except transient ischemic attack

2. All deaths

3. Death from cardiovascular events

4. Effects on glucose metabolism (fasting plasma glucose, postprandial glucose, new onset of diabetes mellitus)

5. Incidence of subset of primary endpoint

 5-1. Sudden death

 5-2. Cerebrovascular events

 5-3. Cardiac events

 5-4. Renal dysfunction

6. New occurrence of atrial fibrillation

7. Safety

8. Proportion of the subjects who withdrew from the allocated treatment

  1. Abbreviations: CABG, coronary artery bypass graft; ESRD, end-stage renal disease; PCI, percutaneous coronary intervention.
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