Trial Outcomes & Findings for Efficacy of Long Term Plavix Therapy Post Angioplasty (NCT NCT02327741)

NCT ID: NCT02327741

Last Updated: 2020-04-29

Results Overview

number of patients with major bleeding need transfusion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1010 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

Measure	Plavix Short Term taking plavix less than 12 months plavix: taking plavix less than 12 months	Plavix Long Term taking plavix more than 12 months plavix: taking plavix more than 12 months
Overall Study STARTED	502	508
Overall Study COMPLETED	502	508
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Long Term Plavix Therapy Post Angioplasty

Baseline characteristics by cohort

Measure	Plavix Long Term n=508 Participants taking plavix more than 12 months plavix: taking plavix more than 12 months	Plavix Short Term n=502 Participants taking plavix less than 12 months plavix: taking plavix less than 12 months	Total n=1010 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants	60.1 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants	180 Participants n=7 Participants	364 Participants n=5 Participants
Sex: Female, Male Male	324 Participants n=5 Participants	322 Participants n=7 Participants	646 Participants n=5 Participants
type of stents drug eluting stents	328 Participants n=5 Participants	327 Participants n=7 Participants	655 Participants n=5 Participants
type of stents metallic stents	180 Participants n=5 Participants	175 Participants n=7 Participants	355 Participants n=5 Participants
coronary risk factors	356 Participants n=5 Participants	351 Participants n=7 Participants	707 Participants n=5 Participants
which coronary vessel involved LAD( left anterior descending)	392 Participants n=5 Participants	400 Participants n=7 Participants	792 Participants n=5 Participants
which coronary vessel involved LCX ( left circumflex)	78 Participants n=5 Participants	80 Participants n=7 Participants	158 Participants n=5 Participants
which coronary vessel involved RCA ( right coronary artery)	38 Participants n=5 Participants	22 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

number of patients with major bleeding need transfusion

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Number of Patients With Major Bleeding Need Transfusion	7 Participants	10 Participants

PRIMARY outcome

Timeframe: 12 month

The number of patients with myocardial infarction need hospital admission

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Number of Patients With Myocardial Infarction Need Hospital Admission	5 Participants	7 Participants

PRIMARY outcome

Timeframe: 12 months

the number of patients with major vascular brain accidents ( CVA) proved by CT scan

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Number of Patients With Central Vascular Accidents Proved by CT Scan	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 12 months

the number patients with death due to cardiac causes

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Number of Patients With Death Due to Cardiac Causes	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 months

need for redo bypass surgery and redo angioplasty

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty	15 Participants	14 Participants

PRIMARY outcome

Timeframe: 12 months

the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Number of Patients With Minor Bleeding	13 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

the number of patients who are able to take plavix concerning compliance and economic issues

Outcome measures

Measure	Plavix Short Term n=502 Participants taking plavix less than 12 months	Plavix Long Term n=508 Participants taking plavix more than 12 months
Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues	500 Participants	506 Participants

Adverse Events

Plavix Short Term

Serious events: 20 serious events

Other events: 13 other events

Deaths: 1 deaths

Plavix Long Term

Serious events: 14 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Plavix Short Term n=502 participants at risk taking plavix less than 12 months	Plavix Long Term n=508 participants at risk taking plavix more than 12 months
Blood and lymphatic system disorders bleeding	4.0% 20/502 • Number of events 20	2.8% 14/508 • Number of events 14

Other adverse events

Measure	Plavix Short Term n=502 participants at risk taking plavix less than 12 months	Plavix Long Term n=508 participants at risk taking plavix more than 12 months
Blood and lymphatic system disorders minor bleeding	2.6% 13/502 • Number of events 13	0.79% 4/508 • Number of events 4

Additional Information

Professor

shiraz university of medical sciences

Phone: 009836250352

Email: kojurij@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place