AtherosclerosisPhase 2CASCADENCT00228423

Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)

A Phase 2 study testing Clopidogrel 75 mg daily and water pill daily in people with Atherosclerosis, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerosis
What is being tested?: Clopidogrel 75 mg daily and water pill daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 113 participants
Where: 1 siteCanada
Study dates: May 2006to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Who cannot join

Emergency surgery
Valve surgery
Redo CABG
Left ventricle ejection fraction < 25%
Serum creatinine > 130 µmol/L
Preoperative use of clopidogrel (with the exception of the current admission)

Show all 11Show fewer

Preoperative use of warfarin; allergy to aspirin or clopidogrel.
History of cerebrovascular accident
History of severe liver disease
Morbid obesity
Current malignancy

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass?

Read the detailed description

Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.

Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.

Conditions: Atherosclerosis
Being tested: Clopidogrel 75 mg daily, water pill daily
Keywords: Saphenous vein, Intimal hyperplasia, Coronary artery bypass graft surgery, Antiplatelet therapy, Clopidogrel, Saphenous vein graft disease
Medical subject headings: Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clopidogrel 75 mg dailyDrug
Daily dose of 75 mg Clopidogrel
water pill dailyDrug
Daily dose of water pill (placebo)

Study groups in NCT00228423
Study group	Role	What they receive
75mg Clopidogrel	Active comparator	75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Receives: Drug: Clopidogrel 75 mg daily
Placebo	Placebo comparator	Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Receives: Drug: water pill daily

What is being measured

The primary outcome is the main question the study is designed to answer.

Vein Graft Intimal Area
IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed
Measured: One year following surgery

Secondary outcomes (3)

Vein Graft Angiographic Patency
Postoperative angiogram 12 months post-CABG
Measured: One year following surgery
Incidence of Major Adverse Coronary Events Within One Year Following Surgery
Measured: 1 year
Incidence of Major Bleeding Events Within One Year Following Surgery
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Jul 2009

First posted28 Sep 2005 (estimated)
Study startMay 2006
Primary completionJun 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for AtherosclerosisStudies of the same condition, open and under way.
More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00228423
Sponsor's protocol ID: UOHI 2006-111
Acronym: CASCADE
Status last verified: Mar 2021
First submitted: 26 Sep 2005
Last updated: 27 Apr 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
PubMed 8772748
Motwani JG, Topol EJ. Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention. Circulation. 1998 Mar 10;97(9):916-31. doi: 10.1161/01.cir.97.9.916.
PubMed 9521341
Jawien A, Bowen-Pope DF, Lindner V, Schwartz SM, Clowes AW. Platelet-derived growth factor promotes smooth muscle migration and intimal thickening in a rat model of balloon angioplasty. J Clin Invest. 1992 Feb;89(2):507-11. doi: 10.1172/JCI115613.
PubMed 1531345
Herbert JM, Dol F, Bernat A, Falotico R, Lale A, Savi P. The antiaggregating and antithrombotic activity of clopidogrel is potentiated by aspirin in several experimental models in the rabbit. Thromb Haemost. 1998 Sep;80(3):512-8.
PubMed 9759636
Herbert JM, Tissinier A, Defreyn G, Maffrand JP. Inhibitory effect of clopidogrel on platelet adhesion and intimal proliferation after arterial injury in rabbits. Arterioscler Thromb. 1993 Aug;13(8):1171-9. doi: 10.1161/01.atv.13.8.1171.
PubMed 8343491
Hermann A, Weber AA, Schror K. Clopidogrel inhibits platelet adhesion and platelet-dependent mitogenesis in vascular smooth muscle cells. Thromb Res. 2002 Jan 15;105(2):173-5. doi: 10.1016/s0049-3848(01)00403-0. No abstract available.
PubMed 11958809
Harker LA, Marzec UM, Kelly AB, Chronos NR, Sundell IB, Hanson SR, Herbert JM. Clopidogrel inhibition of stent, graft, and vascular thrombogenesis with antithrombotic enhancement by aspirin in nonhuman primates. Circulation. 1998 Dec 1;98(22):2461-9. doi: 10.1161/01.cir.98.22.2461.
PubMed 9832493
Cadroy Y, Bossavy JP, Thalamas C, Sagnard L, Sakariassen K, Boneu B. Early potent antithrombotic effect with combined aspirin and a loading dose of clopidogrel on experimental arterial thrombogenesis in humans. Circulation. 2000 Jun 20;101(24):2823-8. doi: 10.1161/01.cir.101.24.2823.
PubMed 10859288
Bhatt DL, Chew DP, Hirsch AT, Ringleb PA, Hacke W, Topol EJ. Superiority of clopidogrel versus aspirin in patients with prior cardiac surgery. Circulation. 2001 Jan 23;103(3):363-8. doi: 10.1161/01.cir.103.3.363.
PubMed 11157686
Fox KA, Mehta SR, Peters R, Zhao F, Lakkis N, Gersh BJ, Yusuf S; Clopidogrel in Unstable angina to prevent Recurrent ischemic Events Trial. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-ST-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial. Circulation. 2004 Sep 7;110(10):1202-8. doi: 10.1161/01.CIR.0000140675.85342.1B. Epub 2004 Aug 16.
PubMed 15313956
Kulik A, Le May M, Wells GA, Mesana TG, Ruel M. The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]. Curr Control Trials Cardiovasc Med. 2005 Oct 11;6(1):15. doi: 10.1186/1468-6708-6-15.
PubMed 16219100
Kulik A, Le May MR, Voisine P, Tardif JC, Delarochelliere R, Naidoo S, Wells GA, Mesana TG, Ruel M. Aspirin plus clopidogrel versus aspirin alone after coronary artery bypass grafting: the clopidogrel after surgery for coronary artery disease (CASCADE) Trial. Circulation. 2010 Dec 21;122(25):2680-7. doi: 10.1161/CIRCULATIONAHA.110.978007. Epub 2010 Dec 6.
PubMed 21135365
Kulik A, Voisine P, Mathieu P, Masters RG, Mesana TG, Le May MR, Ruel M. Statin therapy and saphenous vein graft disease after coronary bypass surgery: analysis from the CASCADE randomized trial. Ann Thorac Surg. 2011 Oct;92(4):1284-90; discussion 1290-1. doi: 10.1016/j.athoracsur.2011.04.107.
PubMed 21958773
Une D, Kulik A, Voisine P, Le May M, Ruel M. Correlates of saphenous vein graft hyperplasia and occlusion 1 year after coronary artery bypass grafting: analysis from the CASCADE randomized trial. Circulation. 2013 Sep 10;128(11 Suppl 1):S213-8. doi: 10.1161/CIRCULATIONAHA.112.000328.
PubMed 24030409
Une D, Al-Atassi T, Kulik A, Voisine P, Le May M, Ruel M. Impact of clopidogrel plus aspirin versus aspirin alone on the progression of native coronary artery disease after bypass surgery: analysis from the Clopidogrel After Surgery for Coronary Artery DiseasE (CASCADE) randomized trial. Circulation. 2014 Sep 9;130(11 Suppl 1):S12-8. doi: 10.1161/CIRCULATIONAHA.113.008227.
PubMed 25200049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass?
ClinicalTrials.gov ID: NCT00228423
Acronym / sponsor ID: CASCADE / UOHI 2006-111
Conditions: Atherosclerosis
Keywords: Saphenous vein, Intimal hyperplasia, Coronary artery bypass graft surgery, Antiplatelet therapy, Clopidogrel, Saphenous vein graft disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Ottawa Heart Institute Research CorporationUniversity, hospital or other
Collaborators: Sanofi, Bristol-Myers Squibb
Study start: May 2006
Primary completion: Jun 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 28 Sep 2005 (estimated)
Results: Posted 27 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
75mg Clopidogrel	Active comparator	Drug: Clopidogrel 75 mg daily75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
Placebo	Placebo comparator	Drug: water pill dailyWater pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Key exclusion criteria (11 listed)

Emergency surgery
Valve surgery
Redo CABG
Left ventricle ejection fraction < 25%
Serum creatinine > 130 µmol/L

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
Clopidogrel 75 mg dailyDaily dose of 75 mg Clopidogrel	Drug	75mg Clopidogrel
water pill dailyDaily dose of water pill (placebo)	Drug	Placebo

Primary outcome

Vein Graft Intimal Area
Time frame: One year following surgery
IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed

3 secondary outcomes

Vein Graft Angiographic Patency
Time frame: One year following surgery
Incidence of Major Adverse Coronary Events Within One Year Following Surgery
Time frame: 1 year
Incidence of Major Bleeding Events Within One Year Following Surgery
Time frame: 1 year

Results and safety

Results posted to the registry on 27 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
75mg Clopidogrel	56	46
Placebo	57	45

Primary outcome: Vein Graft Intimal Area

Time frame: One year following surgery. Mean (Standard Deviation). Unit: mm

Measure	75mg Clopidogrel n = 46	Placebo n = 44
Value	4.1 (2.0)	4.5 (2.1)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
75mg Clopidogrel	4 of 56 (7.1%)	3 of 56 (5.4%)	0 of 56
Placebo	5 of 57 (8.8%)	3 of 57 (5.3%)	1 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8772748Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
Background: PubMed 9521341Motwani JG, Topol EJ. Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention. Circulation. 1998 Mar 10;97(9):916-31. doi: 10.1161/01.cir.97.9.916.
Background: PubMed 1531345Jawien A, Bowen-Pope DF, Lindner V, Schwartz SM, Clowes AW. Platelet-derived growth factor promotes smooth muscle migration and intimal thickening in a rat model of balloon angioplasty. J Clin Invest. 1992 Feb;89(2):507-11. doi: 10.1172/JCI115613.
Background: PubMed 9759636Herbert JM, Dol F, Bernat A, Falotico R, Lale A, Savi P. The antiaggregating and antithrombotic activity of clopidogrel is potentiated by aspirin in several experimental models in the rabbit. Thromb Haemost. 1998 Sep;80(3):512-8.
Background: PubMed 8343491Herbert JM, Tissinier A, Defreyn G, Maffrand JP. Inhibitory effect of clopidogrel on platelet adhesion and intimal proliferation after arterial injury in rabbits. Arterioscler Thromb. 1993 Aug;13(8):1171-9. doi: 10.1161/01.atv.13.8.1171.
Background: PubMed 11958809Hermann A, Weber AA, Schror K. Clopidogrel inhibits platelet adhesion and platelet-dependent mitogenesis in vascular smooth muscle cells. Thromb Res. 2002 Jan 15;105(2):173-5. doi: 10.1016/s0049-3848(01)00403-0. No abstract available.
Background: PubMed 9832493Harker LA, Marzec UM, Kelly AB, Chronos NR, Sundell IB, Hanson SR, Herbert JM. Clopidogrel inhibition of stent, graft, and vascular thrombogenesis with antithrombotic enhancement by aspirin in nonhuman primates. Circulation. 1998 Dec 1;98(22):2461-9. doi: 10.1161/01.cir.98.22.2461.
Background: PubMed 10859288Cadroy Y, Bossavy JP, Thalamas C, Sagnard L, Sakariassen K, Boneu B. Early potent antithrombotic effect with combined aspirin and a loading dose of clopidogrel on experimental arterial thrombogenesis in humans. Circulation. 2000 Jun 20;101(24):2823-8. doi: 10.1161/01.cir.101.24.2823.
Background: PubMed 11157686Bhatt DL, Chew DP, Hirsch AT, Ringleb PA, Hacke W, Topol EJ. Superiority of clopidogrel versus aspirin in patients with prior cardiac surgery. Circulation. 2001 Jan 23;103(3):363-8. doi: 10.1161/01.cir.103.3.363.
Background: PubMed 15313956Fox KA, Mehta SR, Peters R, Zhao F, Lakkis N, Gersh BJ, Yusuf S; Clopidogrel in Unstable angina to prevent Recurrent ischemic Events Trial. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-ST-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial. Circulation. 2004 Sep 7;110(10):1202-8. doi: 10.1161/01.CIR.0000140675.85342.1B. Epub 2004 Aug 16.
Results publication: PubMed 16219100Kulik A, Le May M, Wells GA, Mesana TG, Ruel M. The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]. Curr Control Trials Cardiovasc Med. 2005 Oct 11;6(1):15. doi: 10.1186/1468-6708-6-15.
Results publication: PubMed 21135365Kulik A, Le May MR, Voisine P, Tardif JC, Delarochelliere R, Naidoo S, Wells GA, Mesana TG, Ruel M. Aspirin plus clopidogrel versus aspirin alone after coronary artery bypass grafting: the clopidogrel after surgery for coronary artery disease (CASCADE) Trial. Circulation. 2010 Dec 21;122(25):2680-7. doi: 10.1161/CIRCULATIONAHA.110.978007. Epub 2010 Dec 6.
University of Ottawa Heart Institute WebsiteLink provided by the sponsor.

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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.

Marc Ruel, MD, MPH principal investigator

Ottawa Heart Institute Research Corporation

Alexander Kulik, MD study director

Ottawa Heart Institute Research Corporation

Michel Le May, MD study director

Ottawa Heart Institute Research Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clopidogrel 75 mg daily and water pill daily in people with Atherosclerosis, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

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 1 inclusion and 11 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: finished, as of the sponsor's last update on 27 Apr 2021. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vein Graft Intimal Area (time frame: One year following surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00228423, which also lists 16 linked publications.

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 27 Apr 2021.