Coronary AtherosclerosisPhase 3AFRICANCT01030328
AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis
A Phase 3 study testing TriLipix in people with Coronary Atherosclerosis, run by Piedmont Healthcare at 1 site in United States.
Trial summary
This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin) or the comparison treatment (a placebo). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- TriLipix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- CAC 30-400, within 12 months of screening visit, OR intermediate stenosis on coronary artery CTA or invasive angiography (40-69% visual estimation) without the presence of obstructive (≥70% visual estimation) Stenosis within 3 months of screening visit
- LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
- TG>150 mg/dL and TG/HDL>3.5 at screening or baseline visit
- 10 Year Framingham risk score of ≤ 10%
- Ability and willingness to provide consent and Authorization for use of PHI
Who cannot join
- Previous coronary revascularization (PCI, CABG)
- Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents, intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorption agents and other anti-lipemic agents.)
- Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia, etc.)
- Creatinine 1.5 mg/dL or greater at baseline visit
- Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
- Inability to perform CTA:
Show all 14Show fewer
- Arrhythmia precluding diagnostic CT examination
- Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
- Uncontrolled hypertension (SBP>180 mmHg or DBP>130 mmHg on stable treatment)
- Decompensated heart failure (NYHA class IV) at the time of enrollment
- Known Pregnancy
- Inability or unwillingness to consent and Authorization for use of PHI
- Presence of any co-morbidity that makes life expectancy less than 24 months
- Inability or unwillingness to comply with follow up procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate
This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin) or the comparison treatment (a placebo). Comparison of the effect on the makeup of plaque will be done by using coronary artery computed tomography angiography (CTA), which all participants will have at enrollment and at the end of the study (18 months after enrollment).
Read the detailed description
This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Comparison of the effect on the makeup of plaque will be done by using coronary artery CTA, which all participants will have at enrollment and at the end of the study.
Those who meet the eligibility criteria and sign the informed consent will be enrolled on study. Patients will be instructed on nutritional guidelines and other lifestyle changes for heart-healthy living.
If a patient has had a coronary CTA within the past two (2) months, they will not undergo the procedure at enrollment. If the patient has not had a coronary CTA within the past two (2) months, they will undergo a coronary CTA with contrast. Patients will be randomly assigned to receive either the study treatment (135 mg of TriLipix plus 40 mg of Atorvastatin) or the comparison treatment (a placebo or two pills that contains no active treatment). They will have a 50% chance of receiving the study treatment and a 50% chance of receiving the comparison treatment. This is a double-blind study, which means the patient, the research staff, and the physician will not know which treatment the patient is receiving. However, in case of an emergency, this information is immediately available to the physician.
Follow-up visits will occur at 3, 6, 12, and 18 months. All patients will have a CTA at the end of treatment.
- Conditions
- Coronary Atherosclerosis
- Being tested
- Placebo, TriLipix
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 sugar pills by mouth once a day.
TriLipixDrug
135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
| Study group | Role | What they receive |
|---|---|---|
| TriLipix + Atorvastatin | Active comparator | Two tables of TriLipix + Atorvastatin taken once a day by mouth. Receives: Drug: TriLipix |
| 2 | Placebo comparator | 2 sugar pills Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent
Measured: 18, 24, 30, and 36 months after initiation
Secondary outcomes (1)
The secondary endpoint of the study will be the change in PAV of the "Study Lesion" from baseline to follow-up. PAV will be expressed as a ratio of the plaque volume/total vessel volume.
Measured: 24, 30, and 36 months after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Lack of patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Miller, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030328
- Sponsor's protocol ID
- PH09001
- Acronym
- AFRICA
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2009
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate
- ClinicalTrials.gov ID
- NCT01030328
- Acronym / sponsor ID
- AFRICA / PH09001
- Conditions
- Coronary Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin) or the comparison treatment (a placebo). Comparison of the effect on the makeup of plaque will be done by using coronary artery computed tomography angiography (CTA), which all participants will have at enrollment and at the end of the study (18 months after enrollment).
Detailed description
This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Comparison of the effect on the makeup of plaque will be done by using coronary artery CTA, which all participants will have at enrollment and at the end of the study.
Those who meet the eligibility criteria and sign the informed consent will be enrolled on study. Patients will be instructed on nutritional guidelines and other lifestyle changes for heart-healthy living.
If a patient has had a coronary CTA within the past two (2) months, they will not undergo the procedure at enrollment. If the patient has not had a coronary CTA within the past two (2) months, they will undergo a coronary CTA with contrast. Patients will be randomly assigned to receive either the study treatment (135 mg of TriLipix plus 40 mg of Atorvastatin) or the comparison treatment (a placebo or two pills that contains no active treatment). They will have a 50% chance of receiving the study treatment and a 50% chance of receiving the comparison treatment. This is a double-blind study, which means the patient, the research staff, and the physician will not know which treatment the patient is receiving. However, in case of an emergency, this information is immediately available to the physician.
Follow-up visits will occur at 3, 6, 12, and 18 months. All patients will have a CTA at the end of treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TriLipix + Atorvastatin | Active comparator | Drug: TriLipixTwo tables of TriLipix + Atorvastatin taken once a day by mouth. |
| 2 | Placebo comparator | Drug: Placebo2 sugar pills |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-85
- CAC 30-400, within 12 months of screening visit, OR intermediate stenosis on coronary artery CTA or invasive angiography (40-69% visual estimation) without the presence of obstructive (≥70% visual estimation) Stenosis within 3 months of screening visit
- LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
- TG>150 mg/dL and TG/HDL>3.5 at screening or baseline visit
- 10 Year Framingham risk score of ≤ 10%
Key exclusion criteria (14 listed)
- Previous coronary revascularization (PCI, CABG)
- Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents, intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorption agents and other anti-lipemic agents.)
- Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia, etc.)
- Creatinine 1.5 mg/dL or greater at baseline visit
- Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 sugar pills by mouth once a day. | Drug | 2 |
| TriLipix135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day | Drug | TriLipix + Atorvastatin |
Primary outcome
Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent
Time frame: 18, 24, 30, and 36 months after initiation
1 secondary outcome
The secondary endpoint of the study will be the change in PAV of the "Study Lesion" from baseline to follow-up. PAV will be expressed as a ratio of the plaque volume/total vessel volume.
Time frame: 24, 30, and 36 months after initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Miller, MD principal investigator
Piedmont Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TriLipix in people with Coronary Atherosclerosis, run by Piedmont Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent (time frame: 18, 24, 30, and 36 months after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.