Trial Outcomes & Findings for APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3 (NCT NCT00138034)

NCT ID: NCT00138034

Last Updated: 2012-04-30

Results Overview

Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 49 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2012-04-30

Participant Flow

Patients were included from 1 january 2005 until december 2009

Participant milestones

Measure	Percutaeous Coronary Intervention (PCI) Stenting of culprit lesion followed by dual antiplatelet therapy	Conservative Treatment Conservative treatment of culprit lesion with dual antiplatelet therapy
Overall Study STARTED	26	23
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

Baseline characteristics by cohort

Measure	Percutaeous Coronary Intervention (PCI) n=26 Participants Stenting of culprit lesion followed by dual antiplatelet therapy	Conservative Treatment n=23 Participants Conservative treatment of culprit lesion with dual antiplatelet therapy	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants	59 years STANDARD_DEVIATION 13 • n=7 Participants	59 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment Netherlands	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Austria	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Australia	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography

Outcome measures

Measure	Percutaeous Coronary Intervention (PCI) n=26 Participants Stenting of culprit lesion followed by dual antiplatelet therapy	Conservative Treatment n=23 Participants Conservative treatment of culprit lesion with dual antiplatelet therapy
6-month Reocclusion	1 participants	4 participants

SECONDARY outcome

Timeframe: 6 months

The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.

Outcome measures

Measure	Percutaeous Coronary Intervention (PCI) n=26 Participants Stenting of culprit lesion followed by dual antiplatelet therapy	Conservative Treatment n=23 Participants Conservative treatment of culprit lesion with dual antiplatelet therapy
Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography	4 participants	7 participants

Adverse Events

Percutaeous Coronary Intervention (PCI)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conservative Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Percutaeous Coronary Intervention (PCI) n=26 participants at risk Stenting of culprit lesion followed by dual antiplatelet therapy	Conservative Treatment n=23 participants at risk Conservative treatment of culprit lesion with dual antiplatelet therapy
Nervous system disorders intracerebral bleeding	3.8% 1/26 • Number of events 1	0.00% 0/23

Other adverse events

Adverse event data not reported

Additional Information

Professor Doctor F.W.A. Verheugt

Radboud University Medical Center Nijmegen

Phone: +31(0)24-3614533

Email: f.verheugt@cardio.umcn.nl

Results disclosure agreements

• Principal investigator is a sponsor employee Freek W.A. Verheugt has to following potential conflict of interest: 1. received educational and research grants from Bayer Healthcare, Roche, Eli Lilly and Boehringer Ingelheim 2. received honoraria for consultancies from Daiichi-Sankyo, Eli Lilly, Merck, The Medicines Company and Bayer Healthcare
• Publication restrictions are in place

Restriction type: OTHER