Trial Outcomes & Findings for Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis (NCT NCT01560780)

NCT ID: NCT01560780

Last Updated: 2019-10-30

Results Overview

Number of patients with intragraft thrombus seen at 12 month follow-up by optical coherence tomography in imaged saphenous vein graft

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-10-30

Participant Flow

Participant milestones

Measure	Arm 1: Prasugrel prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Overall Study STARTED	42	42
Overall Study Clinical Follow-Up at 12 Months	42	42
Overall Study Completed Study Drug for 12 Months	27	27
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Measure	Arm 1: Prasugrel prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Overall Study Death	2	1
Overall Study Patient Preference	11	11

Baseline Characteristics

Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis

Baseline characteristics by cohort

Measure	Arm 1: Prasugrel n=42 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=42 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel	Total n=84 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 7 • n=93 Participants	64 years STANDARD_DEVIATION 6 • n=4 Participants	64 years STANDARD_DEVIATION 6 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	41 Participants n=4 Participants	82 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) White	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable OCT. In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 28 had interpretable OCT.

Number of patients with intragraft thrombus seen at 12 month follow-up by optical coherence tomography in imaged saphenous vein graft

Outcome measures

Measure	Arm 1: Prasugrel n=25 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=28 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Prevalence of Intragraft Thrombus at 12-month Follow-up Optical Coherence Tomography Imaging	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 12 months

Number of patients with major bleeding defined by the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries criteria.

Outcome measures

Measure	Arm 1: Prasugrel n=42 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=42 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Number of Patients With Severe Bleeding Using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) Criteria	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography).

Number of patients with angiographic saphenous vein graft failure (defined as =75% SVG diameter stenosis in at least one saphenous vein graft)

Outcome measures

Measure	Arm 1: Prasugrel n=29 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=30 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Number of Patients With Angiographic Saphenous Vein Graft Failure	7 Participants	12 Participants

SECONDARY outcome

Timeframe: 12 months

Population: In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable IVUS. In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 27 had interpretable IVUS.

Total target saphenous vein graft atheroma volume (mm3) as assessed by Intravascular ultrasound imaging in imaged saphenous vein grafts.

Outcome measures

Measure	Arm 1: Prasugrel n=25 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=27 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography	349 mm3 Standard Deviation 189	358 mm3 Standard Deviation 175

SECONDARY outcome

Timeframe: 12 months

Population: In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 12 had interpretable NIRS. In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 20 had interpretable NIRS.

Lipid core burden as measured by Lipid Core Burden Index on near infrared intracoronary spectroscopy imaging of saphenous vein graft. Lipid Core Burden Index is defined as the fraction of pixels within the scanned region with a probability >0.60 that a lipid core plaque is present (calculated by an algorithm developed to identify the NIRS signals associated with the molecular structure of lipids), multiplied by 1000 using EchoPlaque software (INDEC Medical Systems; Los Altos, CA) . Thus, the lipid core burden index (LCBI) is a quantitative summary metric of the probability of the presence of lipid within the scanned region, with a range of 0-1000, with higher indices indicating a higher proportion of pixels with a >0.6 probability of lipid being present in the pullback of the catheter along the length of the entire vessel.

Outcome measures

Measure	Arm 1: Prasugrel n=13 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=20 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Saphenous Vein Graft Lipid Core Burden Index, as Assessed at Near-infrared Intracoronary Spectroscopy	7.5 units on a scale Standard Deviation 9.3	7.4 units on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: 12 months

Number of patients with the composite outcome of death, acute coronary syndrome, or coronary revascularization.

Outcome measures

Measure	Arm 1: Prasugrel n=42 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=42 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Major Adverse Cardiac Events, Defined as the Composite of Death, Acute Coronary Syndrome, or Coronary Revascularization) During Follow-up	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable IVUS. In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 27 had interpretable IVUS.

On IVUS images, atheroma volume was defined as the sum of the cross-sectional areas between the leading edges of the lumen and external elastic membrane. Total Target SVG atheroma volume was calculated as:

∑(EEM area - Lumen area).

Normalized atheroma volume represents the atheroma volume corrected for pullback length, and this parameter was calculated as:

∑(EEM area - Lumen area)/number of frames in pullback

Outcome measures

Measure	Arm 1: Prasugrel n=25 Participants prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=27 Participants placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Normalized Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography	0.093 mm3/frame Standard Deviation 0.045	0.079 mm3/frame Standard Deviation 0.035

Adverse Events

Arm 1: Prasugrel

Serious events: 9 serious events

Other events: 0 other events

Deaths: 2 deaths

Arm 2: Placebo

Serious events: 4 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm 1: Prasugrel n=42 participants at risk prasugrel 10 mg by mouth daily Prasugrel: one 10 mg tablet by mouth daily	Arm 2: Placebo n=42 participants at risk placebo by mouth once daily Placebo: placebo similar in appearance to prasugrel
Blood and lymphatic system disorders Severe GUSTO bleeding	2.4% 1/42 • 12 months	0.00% 0/42 • 12 months
General disorders Death	4.8% 2/42 • 12 months	2.4% 1/42 • 12 months
Cardiac disorders Acute coronary syndrome	4.8% 2/42 • 12 months	4.8% 2/42 • 12 months
Cardiac disorders Percutaneous Coronary Intervention	14.3% 6/42 • 12 months	4.8% 2/42 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Shuaib Abdullah

VA North Texas Healthcare System

Phone: 214-857-1458

Email: shuaib.abdullah@va.gov

Results disclosure agreements

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