Trial Outcomes & Findings for Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China (NCT NCT03491891)
NCT ID: NCT03491891
Last Updated: 2019-09-20
Results Overview
very late stent thrombosis demonstrated by coronary angiography
Recruitment status
COMPLETED
Target enrollment
8476 participants
Primary outcome timeframe
Five years
Results posted on
2019-09-20
Participant Flow
Participant milestones
| Measure |
Derivation Cohort
Patients enrolled in the study in Jilin University First Hospital, no interventions will be administrated
|
Validation Cohort
Patiens enrolled in the study in First affiliated Hospital of Shantou University, no interventions will be administrated
|
|---|---|---|
|
Overall Study
STARTED
|
6038
|
2438
|
|
Overall Study
COMPLETED
|
5185
|
2058
|
|
Overall Study
NOT COMPLETED
|
853
|
380
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Derivation Cohort
n=5185 Participants
Patients enrolled in Jilin University First Hospital, no interventions will be administrated
|
Validation Cohort
n=2058 Participants
Patients enrolled in First Affiliated Hosptal of Shantou University, no interventions will be administrated
|
Total
n=7243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.846 years
STANDARD_DEVIATION 9.95 • n=5185 Participants
|
60.00 years
STANDARD_DEVIATION 10.22 • n=2058 Participants
|
59.96 years
STANDARD_DEVIATION 10.18 • n=7243 Participants
|
|
Sex: Female, Male
Female
|
1628 Participants
n=5185 Participants
|
644 Participants
n=2058 Participants
|
2272 Participants
n=7243 Participants
|
|
Sex: Female, Male
Male
|
3557 Participants
n=5185 Participants
|
1414 Participants
n=2058 Participants
|
4971 Participants
n=7243 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
History or Diabetes Mellitus
|
1329 participants
n=5185 Participants
|
550 participants
n=2058 Participants
|
1879 participants
n=7243 Participants
|
|
Hypertension
|
2721 Participants
n=5185 Participants
|
1073 Participants
n=2058 Participants
|
3794 Participants
n=7243 Participants
|
|
Dyslipidaemia
|
1640 Participants
n=5185 Participants
|
515 Participants
n=2058 Participants
|
2155 Participants
n=7243 Participants
|
|
Current smoker
|
2914 Participants
n=5185 Participants
|
1202 Participants
n=2058 Participants
|
4116 Participants
n=7243 Participants
|
|
History of drinking
|
764 Participants
n=5185 Participants
|
327 Participants
n=2058 Participants
|
1091 Participants
n=7243 Participants
|
|
History of stroke/TIA
|
379 Participants
n=5185 Participants
|
170 Participants
n=2058 Participants
|
549 Participants
n=7243 Participants
|
|
History of PVD
|
88 Participants
n=5185 Participants
|
42 Participants
n=2058 Participants
|
130 Participants
n=7243 Participants
|
|
History of heart failure
|
137 Participants
n=5185 Participants
|
58 Participants
n=2058 Participants
|
195 Participants
n=7243 Participants
|
|
Previous CABG
|
144 Participants
n=5185 Participants
|
65 Participants
n=2058 Participants
|
209 Participants
n=7243 Participants
|
|
Previous PCI
|
104 Participants
n=5185 Participants
|
46 Participants
n=2058 Participants
|
150 Participants
n=7243 Participants
|
|
Previous MI
|
357 Participants
n=5185 Participants
|
114 Participants
n=2058 Participants
|
471 Participants
n=7243 Participants
|
|
AMI as admitting diagnosis
|
3160 Participants
n=5185 Participants
|
1258 Participants
n=2058 Participants
|
4418 Participants
n=7243 Participants
|
|
Cardiogenic shock
|
113 Participants
n=5185 Participants
|
17 Participants
n=2058 Participants
|
130 Participants
n=7243 Participants
|
PRIMARY outcome
Timeframe: Five yearsvery late stent thrombosis demonstrated by coronary angiography
Outcome measures
| Measure |
Derivation Cohort
n=5185 Participants
no interventions will be administrated
|
Validation Cohort
n=2058 Participants
no interventions will be administrated
|
|---|---|---|
|
Very Late Stent Thrombosis
|
92 Participants
|
35 Participants
|
Adverse Events
Derivation Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 316 deaths
Validation Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 132 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60