Trial Outcomes & Findings for Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial) (NCT NCT01528709)

NCT ID: NCT01528709

Last Updated: 2018-09-07

Results Overview

Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 173 participants
• Primary outcome timeframe: 1 year after CABG
• Results posted on: 2018-09-07

Participant Flow

Participant milestones

Measure	High-dose Statin Therapy Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year
Overall Study STARTED	86	87
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Measure	High-dose Statin Therapy Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year
Overall Study Death	2	0
Overall Study Withdrawal by Subject	10	15
Overall Study allergy	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High-dose Statin Therapy n=86 Participants Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy n=87 Participants Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year	Total n=173 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 10.4 • n=86 Participants	70.5 years STANDARD_DEVIATION 10.4 • n=87 Participants	68.9 years STANDARD_DEVIATION 10.4 • n=173 Participants
Sex: Female, Male Female	13 Participants n=86 Participants	19 Participants n=87 Participants	32 Participants n=173 Participants
Sex: Female, Male Male	73 Participants n=86 Participants	68 Participants n=87 Participants	141 Participants n=173 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Diabetes	36 Participants n=86 Participants	38 Participants n=87 Participants	74 Participants n=173 Participants

PRIMARY outcome

Timeframe: 1 year after CABG

Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG

Outcome measures

Measure	High-dose Statin Therapy n=123 Vein grafts Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy n=124 Vein grafts Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year
Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year	14 Vein grafts	16 Vein grafts

SECONDARY outcome

Timeframe: Within 1 year after CABG

Vein graft stenosis 1 year after CABG based on CT coronary angiography

Outcome measures

Measure	High-dose Statin Therapy n=123 Vein grafts Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy n=124 Vein grafts Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year
Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography	4 Vein grafts	7 Vein grafts

Adverse Events

High-dose Statin Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Moderate-dose Statin Therapy

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	High-dose Statin Therapy n=86 participants at risk Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year	Moderate-dose Statin Therapy n=87 participants at risk Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year
Metabolism and nutrition disorders Uncontrolled lipid levels	2.3% 2/86	6.9% 6/87
Musculoskeletal and connective tissue disorders Elevated CK levels	0.00% 0/86	1.1% 1/87
Hepatobiliary disorders Elevated liver enzymes	3.5% 3/86	0.00% 0/87

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexander Kulik

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Phone: 5619556300

Email: alex_kulik@yahoo.com

Results disclosure agreements

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