Table 2 Study characteristics and baseline characteristics of participants
| Â | CLOSURE | PC | RESPECT | |||
|---|---|---|---|---|---|---|
Study Characteristics | ||||||
Design | Randomized Controlled trial | Randomized Controlled trial | Randomized Controlled trial | |||
Duration of follow up | 2.0Â years | 4.1Â years | 2.1Â years | |||
Location | Multi-center trial (North America) | Multi-center trial (Europe, Canada, Brazil, Australia) | Multi-center trial (North America) | |||
Total | 909 | 414 | 980 | |||
| Â | Closure | Medical | Closure | Medical | Closure | Medical |
447 | 462 | 204 | 210 | 499 | 481 | |
Participants | ||||||
Age | 46.3+/−9.6 | 45.7+/−9.1 | 44.3+/−10.2 | 44.6+/−10.1 | 45.7+/−9.7 | 46.2+/−10.0 |
Male sex | 52.1% | 51.5% | 45.1% | 54.3% | 53.7% | 55.7% |
Race or ethnic group | ||||||
Asian | 1.6% | 1.7% | NA | NA | NA | NA |
Black | 4.2% | 5.6% | NA | NA | NA | NA |
White | 89.0% | 89.6% | NA | NA | NA | NA |
Hispanic | 6.7% | 4.8% | NA | NA | NA | NA |
Smoking during previous year | 21.5% | 22.6% | 22.5% | 22.4% | 15.0% | 11.4% |
Birth control/HRT | NA | NA | NA | NA | 8.2% | 10.8% |
Deep venous thrombosis | NA | NA | NA | NA | 4.0% | 3.1% |
Medical history (%) | ||||||
Hypertension | 33.8% | 28.4% | 24.0% | 27.6% | 31.7% | 31.2% |
Hypercholesterolemia | 47.4% | 40.9% | 24.5% | 29.5% | 38.9% | 40.1% |
Diabetes Mellitus | NA | NA | 2.5% | 2.9% | 6.6% | 8.3% |
Migraine | NA | NA | 23% | 18.1% | 39.1% | 38.5% |
Family history of cardiovascular disease or cerebrovascular accidents | 55.3% | 55.6% | 26.0% | 19.0% | 27.3% | 22.5% |
Congestive Heart Failure | 0.4% | 0% | NA | NA | 0.6% | 0% |
Ischemic heart disease | 1.3% | 0.9% | 2.0% | 1.9% | 3.8% | 1.9% |
Myocardial infarction | 1.6% | 1.1% | 1.5% | 0.5% | 1.0% | 0.4% |
Valvular dysfunction | 11.0% | 9.7% | 3.9% | 2.4% | NA | NA |
Arrhythmia | 5.8% | 4.1% | NA | NA | NA | NA |
Peripheral vascular disease | 1.1% | 1.5% | 1.5% | 1.0% | 1.0% | 0.2% |
Pulmonary embolus | 0 | 0.9% | NA | NA | NA | NA |
Peripheral embolism | NA | NA | 2.9% | 2.4% | NA | NA |
Previous TIA | NA | NA | NA | NA | 11.6% | 12.7% |
Previous Stroke | NA | NA | NA | NA | 10.6% | 10.6% |
Index neurologic event for study entry | ||||||
Stroke | NA | NA | 80.9% | 77.6% | NA | NA |
Cryptogenic stroke | 72.6% | 71.4% | NA | NA | 100.0% | 100.0% |
TIA | 27.4% | 28.6% | 16.2% | 20.0% | NA | NA |